Indiana University Department of Psychiatry seeks participants with bipolar disorder who are experiencing depression for a medication study.
The study will evaluate the effectiveness of Memantine (nameneda) in the treatment of bipolar depression.
Participants who qualify for the study must have bipolar disorder, be between the ages of 18 and 65 years, not pregnant or breastfeeding, have been suffering from depression for at least the past month and be taking the drug Lamictal.
The study medication, appointments and treatment are provided free of charge. Participants also will be compensated for their time.
For information on the study, call 317-278-0038, extension 2.
iupui
View drug information on Lamictal.
пятница, 27 мая 2011 г.
четверг, 26 мая 2011 г.
New Book Challenges Current Thinking On Depression And Finds Advantages In The Condition
Tom Wootton, author of The Bipolar Advantage, has just announced the release of his second book, The Depression Advantage, a stirring and sometimes controversial look at the depressive condition and its potential benefits for depressed people.
Mr. Wootton is the founder of Bipolar Advantage: bipolaradvantage. A company dedicated to spreading the message that people with mental conditions can lead full and productive lives. His books can be purchased at: bipolaradvantage/store.html
The Depression Advantage is an audacious departure from the accepted doctrine and canon of literature on depression. The book celebrates the advantages of spiritual, personal and social growth possible through the experience of depressed states and challenges current thinking on depression treatment.
Drawing from historical and literary examples ranging from the lives of the Saints to Buddhist parables to pop culture heroes like the X-Men, The Depression Advantage demonstrates that physical, mental, emotional and spiritual pain can be a catalyst for personal growth and transcendent understanding.
The Depression Advantage redefines the scale of functionality for depressed people; teaching them how to reach inside their pain to find a place of spiritual peace, understanding and growth.
Mr. Wootton's first book, The Bipolar Advantage is a revelation. It is one man's journey through the darkness and light of the bipolar condition to a place of spiritual joy, functionality and excellence that holds lessons for everyone with a diagnosis of bipolar.
Raw, honest and brazen, The Bipolar Advantage draws its examples from the real-life experiences of its author,other people with a bipolar diagnosis, and those who have relationships with bipolar people. Pulling no punches, Tom Wootton paints a realistic picture of the bipolar condition in its many faces, then gently guides the reader through the steps necessary to lead an introspective life that greatly ameliorates those symptoms, with the ultimate goal of helping bipolar people gain control of their lives.
Ultimately, The Bipolar Advantage will stand as a guide book for those who don't want to accept a diminished view of their lives after a diagnosis of bipolar. It's a road map to wellness and strength that will stand the test of time and the changing winds of popular bipolar treatment modalities.
Information on both books can be found at: bipolaradvantage.
Mr Wootton will be featured as Keynote Speaker and workshop facilitator at the 17th Annual Conference of the DBSA (Depression and Bipolar Support Alliance) of California on October 12th & 13th. In addition Mr. Wootton is the keynote speaker for the 2007 Annual Conference and Criminal Justice Symposium sponsored by the National Alliance on Mental Illness (NAMI) Pennsylvania held in Harrisburg, PA on Saturday, October 27th at 12:00 pm at the Radisson Penn Harris Hotel. Call 800-223-0500 for information.
Workshops:
Mr. Wootton will be facilitating workshops, entitled "Bipolar in Order," on managing bipolar illness and moving to the next level of functionality for bipolar people and their families, on November 17, 2007 at the Doubletree Hotel in Sacramento. Call or email for details and registration. email protected from spam bots 734-464-3022 or 877-231-(HOPE) 4673 or register online at bipolaradvantage. Other dates and locations are available on the web site.
Mr. Wootton is the founder of Bipolar Advantage: bipolaradvantage. A company dedicated to spreading the message that people with mental conditions can lead full and productive lives. His books can be purchased at: bipolaradvantage/store.html
The Depression Advantage is an audacious departure from the accepted doctrine and canon of literature on depression. The book celebrates the advantages of spiritual, personal and social growth possible through the experience of depressed states and challenges current thinking on depression treatment.
Drawing from historical and literary examples ranging from the lives of the Saints to Buddhist parables to pop culture heroes like the X-Men, The Depression Advantage demonstrates that physical, mental, emotional and spiritual pain can be a catalyst for personal growth and transcendent understanding.
The Depression Advantage redefines the scale of functionality for depressed people; teaching them how to reach inside their pain to find a place of spiritual peace, understanding and growth.
Mr. Wootton's first book, The Bipolar Advantage is a revelation. It is one man's journey through the darkness and light of the bipolar condition to a place of spiritual joy, functionality and excellence that holds lessons for everyone with a diagnosis of bipolar.
Raw, honest and brazen, The Bipolar Advantage draws its examples from the real-life experiences of its author,other people with a bipolar diagnosis, and those who have relationships with bipolar people. Pulling no punches, Tom Wootton paints a realistic picture of the bipolar condition in its many faces, then gently guides the reader through the steps necessary to lead an introspective life that greatly ameliorates those symptoms, with the ultimate goal of helping bipolar people gain control of their lives.
Ultimately, The Bipolar Advantage will stand as a guide book for those who don't want to accept a diminished view of their lives after a diagnosis of bipolar. It's a road map to wellness and strength that will stand the test of time and the changing winds of popular bipolar treatment modalities.
Information on both books can be found at: bipolaradvantage.
Mr Wootton will be featured as Keynote Speaker and workshop facilitator at the 17th Annual Conference of the DBSA (Depression and Bipolar Support Alliance) of California on October 12th & 13th. In addition Mr. Wootton is the keynote speaker for the 2007 Annual Conference and Criminal Justice Symposium sponsored by the National Alliance on Mental Illness (NAMI) Pennsylvania held in Harrisburg, PA on Saturday, October 27th at 12:00 pm at the Radisson Penn Harris Hotel. Call 800-223-0500 for information.
Workshops:
Mr. Wootton will be facilitating workshops, entitled "Bipolar in Order," on managing bipolar illness and moving to the next level of functionality for bipolar people and their families, on November 17, 2007 at the Doubletree Hotel in Sacramento. Call or email for details and registration. email protected from spam bots 734-464-3022 or 877-231-(HOPE) 4673 or register online at bipolaradvantage. Other dates and locations are available on the web site.
среда, 25 мая 2011 г.
Recall Of Counterfeit Zyprexa Batches, UK
The MHRA has been alerted to three counterfeit batches of Zyprexa (Olanzapine) 10 mg tablets. This drug is used in the treatment for patients with schizophrenia, bipolar disorder and similar conditions.
The MHRA has issued a drug alert to recall this product from the market, to minimise the risk to patients. To date, it is believed that two of the batches have reached patient level. We take this very seriously and a criminal investigation is being carried out.
Patients should contact their pharmacist as soon as possible, if they are taking medication from the following; Zyprexa (Olanzapine) 10mg tablets with the batch numbers A229505, A200127, A216454 (or one of these numbers with a prefix or suffix). They should take their medication with them so their pharmacist can return it to Eli Lilly (the manufacturer) for examination. At present there is no evidence of patients having any adverse reactions specifically related to the counterfeit batches. Patients should consult their GP if they have any treatment or health concerns.
Patients with concerns can contact Eli Lilly on 0800 032 0741.
1. Zyprexa contains the active ingredient called Olanzapine. Zyprexa belongs to a group of medicines called antipsychotics. It is indicated in the treatment for schizophrenia and bipolar disorder. Zyprexa is centrally licensed by the European Medicines Agency (EMEA) and we are working in conjunction with them. Eli Lilly is the licence holder. Zyprexa (Olanzapine) is licensed by the EMEA and was licensed on 27 September 1996.
2. The MHRA was informed by Eli Lilly. Eli Lilly was informed by a company who prints labelling for their products, after a repackager had contacted them after becoming suspicious.
3. One person has been arrested and is on bail. They have not yet been charged. MHRA investigatory enquiries are continuing.
4. The initial laboratory tests on the seized counterfeits show that the samples contain approximately 60% of the labelled active ingredient. A counterfeit may also contain harmful ingredients. Work is ongoing to obtain more information about any additional ingredients in these counterfeit tablets, but in the interim we have issued a recall to minimise patient risk.
5. Counterfeits are notoriously difficult to detect with the untrained eye and even experts sometimes require full forensic laboratory tests to determine whether a suspect product is indeed a counterfeit. Although there are some visual differences between genuine and counterfeit stock in this case, they are not all clear. We do not feel that patients should be responsible for physically examining their packs if they bear the suspect batch numbers, therefore we strongly recommend taking the product back to their GP or pharmacist who can contact Eli Lilly and arrange for the product to be returned for analysis. Lilly are the best people to carry out these tests to differentiate the genuine article from the fake.
Class 1 Drug Alert (patient level recall): Counterfeit Parallel Distributed Product - Zyprexa Tablets 10mg
mhra.uk
View drug information on Zyprexa.
The MHRA has issued a drug alert to recall this product from the market, to minimise the risk to patients. To date, it is believed that two of the batches have reached patient level. We take this very seriously and a criminal investigation is being carried out.
Patients should contact their pharmacist as soon as possible, if they are taking medication from the following; Zyprexa (Olanzapine) 10mg tablets with the batch numbers A229505, A200127, A216454 (or one of these numbers with a prefix or suffix). They should take their medication with them so their pharmacist can return it to Eli Lilly (the manufacturer) for examination. At present there is no evidence of patients having any adverse reactions specifically related to the counterfeit batches. Patients should consult their GP if they have any treatment or health concerns.
Patients with concerns can contact Eli Lilly on 0800 032 0741.
1. Zyprexa contains the active ingredient called Olanzapine. Zyprexa belongs to a group of medicines called antipsychotics. It is indicated in the treatment for schizophrenia and bipolar disorder. Zyprexa is centrally licensed by the European Medicines Agency (EMEA) and we are working in conjunction with them. Eli Lilly is the licence holder. Zyprexa (Olanzapine) is licensed by the EMEA and was licensed on 27 September 1996.
2. The MHRA was informed by Eli Lilly. Eli Lilly was informed by a company who prints labelling for their products, after a repackager had contacted them after becoming suspicious.
3. One person has been arrested and is on bail. They have not yet been charged. MHRA investigatory enquiries are continuing.
4. The initial laboratory tests on the seized counterfeits show that the samples contain approximately 60% of the labelled active ingredient. A counterfeit may also contain harmful ingredients. Work is ongoing to obtain more information about any additional ingredients in these counterfeit tablets, but in the interim we have issued a recall to minimise patient risk.
5. Counterfeits are notoriously difficult to detect with the untrained eye and even experts sometimes require full forensic laboratory tests to determine whether a suspect product is indeed a counterfeit. Although there are some visual differences between genuine and counterfeit stock in this case, they are not all clear. We do not feel that patients should be responsible for physically examining their packs if they bear the suspect batch numbers, therefore we strongly recommend taking the product back to their GP or pharmacist who can contact Eli Lilly and arrange for the product to be returned for analysis. Lilly are the best people to carry out these tests to differentiate the genuine article from the fake.
Class 1 Drug Alert (patient level recall): Counterfeit Parallel Distributed Product - Zyprexa Tablets 10mg
mhra.uk
View drug information on Zyprexa.
вторник, 24 мая 2011 г.
Link Between Bipolar Disorder And Risk Of Early Death From Natural Causes
Bipolar disorder appears to increase the risk of early death from medical illnesses, according to a literature review study published as the lead article this week in the journal Psychiatric Services.
The researchers comprehensively reviewed 17 studies involving more than 331,000 patients. Evidence suggested that people with bipolar disorder have a higher mortality from natural causes compared to people in the general population of similar age and gender but without mental illness. The various studies indicated that the risk was from 35 percent to 200 percent higher. The risk is the same for men and women. The most common conditions leading to premature death were heart disease, respiratory diseases, stroke, and endocrine problems such as diabetes.
"The review of data gathered from large population studies suggests that having bipolar disorder is similar to being a smoker in terms of increasing a person's risk of early death," said Dr. Wayne Katon, a University of Washington (UW) professor of psychiatry. He co-authored the study with third-year UW psychiatry resident Babak Roshanaei-Moghaddam. The article is titled, "Premature Mortality from General Medical Illnesses Among Persons with Bipolar Disorder: A Review." Katon is a noted researcher on the interplay between life-shortening medical conditions and mood disorders.
People with bipolar disorder tend to have manic phases and depressed phases in their lives. During mania, they might be too wound up to sleep, their thoughts might race, and they might have boundless energy. During depression, they might feel painfully sad, hopeless, and immobilized.
In the past, the higher premature death rate among people with bipolar disorder was attributed to a higher rate of suicide and accidents. More recently, Katon said, researchers are finding that, while rates of suicides and accidents are indeed greater among those with bipolar disorder compared to the general population, they only partly account for the higher premature death rate. Emerging evidence, Katon said, shows that the majority of early deaths among people with bipolar disorder come from medical conditions.
As psychiatric conditions such as bipolar disorder become more treatable, Katon said, "We're saving people from this illness and losing them to other medical illnesses."
The possible reasons for this higher risk of premature death are manifold. Many factors could be contributing to poor physical health among people with bipolar disorder, according to the published report. These include unhealthy diet, binge eating, lack of exercise, smoking, substance abuse, social deprivation, living alone, homelessness, lack of access to health services, biased attitudes of health professionals towards people with psychiatric illnesses, failure among psychiatrists to address their patient's medical problems, or delaying medical care because of the overriding need for psychiatric treatment.
Biological abnormalities associated with bipolar illness might also be shortening lives, Katon noted. The illness can stress the immune system and the hypothalamic-pituitary axis, a system that controls many body processes. Bipolar disorders also heighten the activity of the sympathetic nervous system, which sets off the fight-or-flight response to stress.
Katon also noted that some new antipsychotic medications used to successfully treat bipolar disorders are safer and more comfortable for the patient in some ways than previous medications, but can cause weight gain leading to obesity and other metabolic changes that predispose people to Type 2 diabetes. Some mood stabilizers, Katon added, also are associated with weight gain and metabolic disorders.
Katon mentioned new attempts to try to reduce premature death in people with bipolar disorder. These include providing psychiatrists and other mental health professionals with guidelines and training in monitoring their patients' basic physical health and teaching them how to advise their patients about smoking cessation, exercise and other preventive measures.
"Changes are also occurring in medical schools to teach new physicians in all specialties how to recognize psychiatric illnesses and to understand the serious health risks associated with mental illness," Katon said.
Increasingly, community mental health centers are adding primary-care physicians and nurse practitioners to the staff to see patients for medical conditions, he said. Medical specialty centers are also adding mental health professionals to diagnose and treat the depression, anxiety and other psychic distress that often accompany serious illnesses.
"Psychiatrists are now on the staff of a growing number of medical specialty clinics, such as centers for diabetes, heart disease and cancer, and at primary-care centers, such as family medicine practices," Katon said. "Mental health professionals are working side-by-side with providers who treat medical illnesses. New approaches to health care and wellness programs are being tested at a number of places to find effective models for preventing premature deaths associated with bipolar disorder and other mental illnesses."
Source: Leila Gray
University of Washington
The researchers comprehensively reviewed 17 studies involving more than 331,000 patients. Evidence suggested that people with bipolar disorder have a higher mortality from natural causes compared to people in the general population of similar age and gender but without mental illness. The various studies indicated that the risk was from 35 percent to 200 percent higher. The risk is the same for men and women. The most common conditions leading to premature death were heart disease, respiratory diseases, stroke, and endocrine problems such as diabetes.
"The review of data gathered from large population studies suggests that having bipolar disorder is similar to being a smoker in terms of increasing a person's risk of early death," said Dr. Wayne Katon, a University of Washington (UW) professor of psychiatry. He co-authored the study with third-year UW psychiatry resident Babak Roshanaei-Moghaddam. The article is titled, "Premature Mortality from General Medical Illnesses Among Persons with Bipolar Disorder: A Review." Katon is a noted researcher on the interplay between life-shortening medical conditions and mood disorders.
People with bipolar disorder tend to have manic phases and depressed phases in their lives. During mania, they might be too wound up to sleep, their thoughts might race, and they might have boundless energy. During depression, they might feel painfully sad, hopeless, and immobilized.
In the past, the higher premature death rate among people with bipolar disorder was attributed to a higher rate of suicide and accidents. More recently, Katon said, researchers are finding that, while rates of suicides and accidents are indeed greater among those with bipolar disorder compared to the general population, they only partly account for the higher premature death rate. Emerging evidence, Katon said, shows that the majority of early deaths among people with bipolar disorder come from medical conditions.
As psychiatric conditions such as bipolar disorder become more treatable, Katon said, "We're saving people from this illness and losing them to other medical illnesses."
The possible reasons for this higher risk of premature death are manifold. Many factors could be contributing to poor physical health among people with bipolar disorder, according to the published report. These include unhealthy diet, binge eating, lack of exercise, smoking, substance abuse, social deprivation, living alone, homelessness, lack of access to health services, biased attitudes of health professionals towards people with psychiatric illnesses, failure among psychiatrists to address their patient's medical problems, or delaying medical care because of the overriding need for psychiatric treatment.
Biological abnormalities associated with bipolar illness might also be shortening lives, Katon noted. The illness can stress the immune system and the hypothalamic-pituitary axis, a system that controls many body processes. Bipolar disorders also heighten the activity of the sympathetic nervous system, which sets off the fight-or-flight response to stress.
Katon also noted that some new antipsychotic medications used to successfully treat bipolar disorders are safer and more comfortable for the patient in some ways than previous medications, but can cause weight gain leading to obesity and other metabolic changes that predispose people to Type 2 diabetes. Some mood stabilizers, Katon added, also are associated with weight gain and metabolic disorders.
Katon mentioned new attempts to try to reduce premature death in people with bipolar disorder. These include providing psychiatrists and other mental health professionals with guidelines and training in monitoring their patients' basic physical health and teaching them how to advise their patients about smoking cessation, exercise and other preventive measures.
"Changes are also occurring in medical schools to teach new physicians in all specialties how to recognize psychiatric illnesses and to understand the serious health risks associated with mental illness," Katon said.
Increasingly, community mental health centers are adding primary-care physicians and nurse practitioners to the staff to see patients for medical conditions, he said. Medical specialty centers are also adding mental health professionals to diagnose and treat the depression, anxiety and other psychic distress that often accompany serious illnesses.
"Psychiatrists are now on the staff of a growing number of medical specialty clinics, such as centers for diabetes, heart disease and cancer, and at primary-care centers, such as family medicine practices," Katon said. "Mental health professionals are working side-by-side with providers who treat medical illnesses. New approaches to health care and wellness programs are being tested at a number of places to find effective models for preventing premature deaths associated with bipolar disorder and other mental illnesses."
Source: Leila Gray
University of Washington
понедельник, 23 мая 2011 г.
FDA Approves RISPERDAL(R) To Treat Adolescents With Schizophrenia And Children And Adolescents With Bipolar Mania
The U.S. Food and Drug
Administration (FDA) today approved RISPERDAL(R) (risperidone) for the
treatment of schizophrenia in adolescents ages 13-17 and for the short-term
treatment of bipolar mania associated with manic or mixed episodes of
bipolar I disorder in children and adolescents ages 10-17.
This approval is based on studies involving more than 430 adolescents,
ages 13-17, in the treatment of schizophrenia and 160 children and
adolescents, ages 10-17, for the short-term treatment of bipolar mania
associated with manic or mixed episodes of bipolar I disorder.
RISPERDAL is marketed in the U.S. by Janssen, L.P. and promoted by
McNeil Pediatrics, a division of McNeil-PPC., Inc.
Janssen is the only U.S. pharmaceutical company exclusively dedicated
to mental health. For more information about RISPERDAL, visit
janssen.
RISPERDAL(R) (risperidone) is indicated in adults for the treatment of
schizophrenia, for the treatment of manic symptoms of acute manic or mixed
episodes associated with bipolar I disorder, for the treatment of
irritability associated with autistic disorder in ages 5-16 years, for the
treatment of schizophrenia in adolescents ages 13-17 years and for the
short-term treatment of bipolar mania associated with bipolar I disorder in
children and adolescents ages 10-17 years.
Important Safety Information For RISPERDAL(R)
Elderly Patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk of death compared to placebo.
RISPERDAL(R) (risperidone) is not approved for the treatment of patients
with Dementia-Related Psychosis.
The most common adverse reactions observed in all clinical trials with
Risperdal occurring at a rate of at least 10% were: somnolence, appetite
increased, fatigue, rhinitis, upper respiratory tract infection, vomiting,
coughing, urinary incontinence, saliva increased, constipation, fever,
tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry
mouth, rash, restlessness, and indigestion.
A rare but serious side effect that has been reported with this kind of
medicine, including RISPERDAL(R), is known as neuroleptic malignant
syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be
serious.
You may have heard the term "tardive dyskinesia." These are usually
persistent, uncontrollable, slow or jerky facial or body movements that can
be caused by all medications of this type. If you have these symptoms, talk
to your health care professional.
Studies suggest an increased risk of elevated blood sugar-related side
effects, and sometimes potentially fatal, in patients treated with this
class of medications, including RISPERDAL(R). Some people may need regular
blood sugar testing.
Some people taking RISPERDAL(R) may feel faint or lightheaded when they
stand up or sit up too quickly. By standing up or sitting up slowly and
following your health care professional's dosing instructions, this side
effect may be reduced or it may go away over time.
You may have heard the term "extrapyramidal symptoms" (EPS). These are
usually persistent movement disorders or muscle disturbances, such as
restlessness, tremors and muscle stiffness. Some people taking RISPERDAL(R)
have these side effects. If you have these symptoms, talk to your health
care professional.
Some medications may interact with RISPERDAL(R). Avoid alcohol while on
RISPERDAL(R).
Inform your health care professional if you are pregnant or if you are
planning to get pregnant while taking RISPERDAL(R). Do not breastfeed if
you are taking RISPERDAL(R).
RISPERDAL(R) may affect your driving ability, therefore, do not drive
or operate machines before talking to your health care professional.
RISPERDAL(R) may affect alertness and motor skills; use caution until
the effect of RISPERDAL(R) is known.
Please see full important U.S. prescribing information for RISPERDAL(R)
at janssen.
Janssen, L.P., based in Titusville, NJ, is the only pharmaceutical
company in the U.S. dedicated solely to mental health. The company
currently markets prescription medications for the treatment of
schizophrenia, bipolar mania and irritability associated with autistic
disorder. For more information about Janssen, L.P., visit
janssen, and for more information on RISPERDAL(R), visit
RISPERDAL.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C., is
headquartered in Raritan, NJ, and has facilities throughout Europe and the
U.S. The company is leveraging drug discovery and drug development in a
variety of therapeutic areas to address unmet medical needs worldwide.
Janssen, L.P.
janssen
View drug information on Risperdal Oral Formulation.
Administration (FDA) today approved RISPERDAL(R) (risperidone) for the
treatment of schizophrenia in adolescents ages 13-17 and for the short-term
treatment of bipolar mania associated with manic or mixed episodes of
bipolar I disorder in children and adolescents ages 10-17.
This approval is based on studies involving more than 430 adolescents,
ages 13-17, in the treatment of schizophrenia and 160 children and
adolescents, ages 10-17, for the short-term treatment of bipolar mania
associated with manic or mixed episodes of bipolar I disorder.
RISPERDAL is marketed in the U.S. by Janssen, L.P. and promoted by
McNeil Pediatrics, a division of McNeil-PPC., Inc.
Janssen is the only U.S. pharmaceutical company exclusively dedicated
to mental health. For more information about RISPERDAL, visit
janssen.
RISPERDAL(R) (risperidone) is indicated in adults for the treatment of
schizophrenia, for the treatment of manic symptoms of acute manic or mixed
episodes associated with bipolar I disorder, for the treatment of
irritability associated with autistic disorder in ages 5-16 years, for the
treatment of schizophrenia in adolescents ages 13-17 years and for the
short-term treatment of bipolar mania associated with bipolar I disorder in
children and adolescents ages 10-17 years.
Important Safety Information For RISPERDAL(R)
Elderly Patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk of death compared to placebo.
RISPERDAL(R) (risperidone) is not approved for the treatment of patients
with Dementia-Related Psychosis.
The most common adverse reactions observed in all clinical trials with
Risperdal occurring at a rate of at least 10% were: somnolence, appetite
increased, fatigue, rhinitis, upper respiratory tract infection, vomiting,
coughing, urinary incontinence, saliva increased, constipation, fever,
tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry
mouth, rash, restlessness, and indigestion.
A rare but serious side effect that has been reported with this kind of
medicine, including RISPERDAL(R), is known as neuroleptic malignant
syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be
serious.
You may have heard the term "tardive dyskinesia." These are usually
persistent, uncontrollable, slow or jerky facial or body movements that can
be caused by all medications of this type. If you have these symptoms, talk
to your health care professional.
Studies suggest an increased risk of elevated blood sugar-related side
effects, and sometimes potentially fatal, in patients treated with this
class of medications, including RISPERDAL(R). Some people may need regular
blood sugar testing.
Some people taking RISPERDAL(R) may feel faint or lightheaded when they
stand up or sit up too quickly. By standing up or sitting up slowly and
following your health care professional's dosing instructions, this side
effect may be reduced or it may go away over time.
You may have heard the term "extrapyramidal symptoms" (EPS). These are
usually persistent movement disorders or muscle disturbances, such as
restlessness, tremors and muscle stiffness. Some people taking RISPERDAL(R)
have these side effects. If you have these symptoms, talk to your health
care professional.
Some medications may interact with RISPERDAL(R). Avoid alcohol while on
RISPERDAL(R).
Inform your health care professional if you are pregnant or if you are
planning to get pregnant while taking RISPERDAL(R). Do not breastfeed if
you are taking RISPERDAL(R).
RISPERDAL(R) may affect your driving ability, therefore, do not drive
or operate machines before talking to your health care professional.
RISPERDAL(R) may affect alertness and motor skills; use caution until
the effect of RISPERDAL(R) is known.
Please see full important U.S. prescribing information for RISPERDAL(R)
at janssen.
Janssen, L.P., based in Titusville, NJ, is the only pharmaceutical
company in the U.S. dedicated solely to mental health. The company
currently markets prescription medications for the treatment of
schizophrenia, bipolar mania and irritability associated with autistic
disorder. For more information about Janssen, L.P., visit
janssen, and for more information on RISPERDAL(R), visit
RISPERDAL.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C., is
headquartered in Raritan, NJ, and has facilities throughout Europe and the
U.S. The company is leveraging drug discovery and drug development in a
variety of therapeutic areas to address unmet medical needs worldwide.
Janssen, L.P.
janssen
View drug information on Risperdal Oral Formulation.
воскресенье, 22 мая 2011 г.
Corcept Therapeutics Announces Negative Results From The Second Of Three Phase 3 Studies Evaluating CORLUX(R) For Treating Psychotic Features
Corcept Therapeutics Incorporated (Nasdaq: CORT), today announced that the second
of its three Phase 3 trials evaluating CORLUX for treating the psychotic
features of Psychotic Major Depression (PMD) was negative.
Study 09 was a randomized, double-blind, placebo-controlled study. The
primary endpoint, a responder analysis, was the proportion of patients with
at least a 50 percent improvement in the Brief Psychiatric Rating Scale
Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 28.
Specifically, the BPRS is an 18-item rating instrument used to assess
psychopathology, and the PSS is a subset of four items in the BPRS that
specifically measure psychosis. The study revealed no meaningful separation
in response between patients receiving CORLUX and patients receiving
placebo. The two key secondary endpoints of Study 09 were similarly
negative.
"As was the case in Study 07, our previously announced Phase 3 clinical
trial, there was an unusually high placebo response rate in Study 09,"
noted Robert L. Roe, M.D., Corcept's President and head of Development. "At
Day 56, for example, approximately 95 percent of the patients in both of
the arms of the study were responders as measured by a 50 percent
improvement in BPRS PSS score."
"Although not the primary or a key secondary endpoint, it is
interesting to note that there was a statistically significant separation
between the CORLUX and placebo groups on an endpoint commonly used to
measure the efficacy of antipsychotic and antidepressant medications,
change from baseline to study end, in this case, Day 56," said Joseph K.
Belanoff, M.D., Corcept's Chief Executive Officer. "However, because of the
already high degree of response in the placebo group, it is difficult to
determine how much additional clinical utility is conferred by this
finding."
Corcept now has one Phase 3 study in progress. "We continue to enroll
patients in Study 06 and expect to announce the results of this trial early
next year," said Dr. Belanoff.
Commenting on Corcept's financial guidance, Fred Kurland, Corcept's
Chief Financial Officer, stated, "Based on the timeline of our clinical
development program, we expect that our available cash and marketable
securities, which were $17.5 million at June 30, 2006, will enable us to
complete and announce the results of our remaining Phase 3 clinical study."
Conference Call and Live Webcast on September 29, 2006
Management will host a conference call on September 29, 2006 at 9:00
a.m. EDT to provide an update on its PMD clinical program. To participate,
please dial 800-257-2101 for domestic calls or 303-262-2130 for
international calls. A telephone replay will also be available by dialing
800-405-2236 for domestic calls or 303-590-3000 for international calls.
The access code is 11072650. The replay will be available until 4:00 p.m.
EDT on October 13, 2006.
A live webcast of the conference call can be accessed at
corcept. The event will be archived and available for replay until
4:00 p.m. EDT on October 13, 2006.
About Psychotic Major Depression
PMD is a serious psychiatric disorder that affects about three million
people in the United States every year. It is more prevalent than either
schizophrenia or manic depression. The disorder is characterized by severe
depression accompanied by delusions, hallucinations or both. People with
PMD are approximately 70 times more likely to commit suicide than the
general population and often require lengthy and expensive hospital stays.
There is no FDA-approved treatment for PMD.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company focused
on developing drugs for treating severe psychiatric and neurological
diseases. Corcept's lead product, CORLUX, is in Phase 3 clinical trials for
treating the psychotic features of PMD. The drug is administered orally to
PMD patients once per day for seven days. CORLUX, a potent GR-II
antagonist, appears to reduce the effects of the elevated and abnormal
release patterns of cortisol seen in PMD. The company has also initiated a
proof-of-concept study to evaluate the ability of CORLUX to mitigate weight
gain associated with the use of olanzapine. For more information, please
visit corcept.
Forward-looking Statements
Statements made in this news release -- other than statements of
historical fact -- are forward-looking statements. These include
information relating to Corcept's PMD clinical development program, the
timing of the completion of its remaining pivotal Phase 3 trial and
projections of the availability of cash. Forward-looking statements are
subject to a number of known and unknown risks and uncertainties that might
cause actual results to differ materially from those expressed or implied
here. For example, there can be no assurances on the efficacy, safety,
enrollment completion or success of clinical trials; the regulatory process
or regulatory approvals; or commercial success. In addition, financial
projections and trial timetables may not be accurate. Risk factors are
explained in the company's SEC filings, all of which are available from its
Web site ( corcept ) or from the SEC's Web site ( sec ).
The company does not have any intention or duty to update forward-looking
statements made in this news release.
Corcept Therapeutics Incorporated
corcept
of its three Phase 3 trials evaluating CORLUX for treating the psychotic
features of Psychotic Major Depression (PMD) was negative.
Study 09 was a randomized, double-blind, placebo-controlled study. The
primary endpoint, a responder analysis, was the proportion of patients with
at least a 50 percent improvement in the Brief Psychiatric Rating Scale
Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 28.
Specifically, the BPRS is an 18-item rating instrument used to assess
psychopathology, and the PSS is a subset of four items in the BPRS that
specifically measure psychosis. The study revealed no meaningful separation
in response between patients receiving CORLUX and patients receiving
placebo. The two key secondary endpoints of Study 09 were similarly
negative.
"As was the case in Study 07, our previously announced Phase 3 clinical
trial, there was an unusually high placebo response rate in Study 09,"
noted Robert L. Roe, M.D., Corcept's President and head of Development. "At
Day 56, for example, approximately 95 percent of the patients in both of
the arms of the study were responders as measured by a 50 percent
improvement in BPRS PSS score."
"Although not the primary or a key secondary endpoint, it is
interesting to note that there was a statistically significant separation
between the CORLUX and placebo groups on an endpoint commonly used to
measure the efficacy of antipsychotic and antidepressant medications,
change from baseline to study end, in this case, Day 56," said Joseph K.
Belanoff, M.D., Corcept's Chief Executive Officer. "However, because of the
already high degree of response in the placebo group, it is difficult to
determine how much additional clinical utility is conferred by this
finding."
Corcept now has one Phase 3 study in progress. "We continue to enroll
patients in Study 06 and expect to announce the results of this trial early
next year," said Dr. Belanoff.
Commenting on Corcept's financial guidance, Fred Kurland, Corcept's
Chief Financial Officer, stated, "Based on the timeline of our clinical
development program, we expect that our available cash and marketable
securities, which were $17.5 million at June 30, 2006, will enable us to
complete and announce the results of our remaining Phase 3 clinical study."
Conference Call and Live Webcast on September 29, 2006
Management will host a conference call on September 29, 2006 at 9:00
a.m. EDT to provide an update on its PMD clinical program. To participate,
please dial 800-257-2101 for domestic calls or 303-262-2130 for
international calls. A telephone replay will also be available by dialing
800-405-2236 for domestic calls or 303-590-3000 for international calls.
The access code is 11072650. The replay will be available until 4:00 p.m.
EDT on October 13, 2006.
A live webcast of the conference call can be accessed at
corcept. The event will be archived and available for replay until
4:00 p.m. EDT on October 13, 2006.
About Psychotic Major Depression
PMD is a serious psychiatric disorder that affects about three million
people in the United States every year. It is more prevalent than either
schizophrenia or manic depression. The disorder is characterized by severe
depression accompanied by delusions, hallucinations or both. People with
PMD are approximately 70 times more likely to commit suicide than the
general population and often require lengthy and expensive hospital stays.
There is no FDA-approved treatment for PMD.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company focused
on developing drugs for treating severe psychiatric and neurological
diseases. Corcept's lead product, CORLUX, is in Phase 3 clinical trials for
treating the psychotic features of PMD. The drug is administered orally to
PMD patients once per day for seven days. CORLUX, a potent GR-II
antagonist, appears to reduce the effects of the elevated and abnormal
release patterns of cortisol seen in PMD. The company has also initiated a
proof-of-concept study to evaluate the ability of CORLUX to mitigate weight
gain associated with the use of olanzapine. For more information, please
visit corcept.
Forward-looking Statements
Statements made in this news release -- other than statements of
historical fact -- are forward-looking statements. These include
information relating to Corcept's PMD clinical development program, the
timing of the completion of its remaining pivotal Phase 3 trial and
projections of the availability of cash. Forward-looking statements are
subject to a number of known and unknown risks and uncertainties that might
cause actual results to differ materially from those expressed or implied
here. For example, there can be no assurances on the efficacy, safety,
enrollment completion or success of clinical trials; the regulatory process
or regulatory approvals; or commercial success. In addition, financial
projections and trial timetables may not be accurate. Risk factors are
explained in the company's SEC filings, all of which are available from its
Web site ( corcept ) or from the SEC's Web site ( sec ).
The company does not have any intention or duty to update forward-looking
statements made in this news release.
Corcept Therapeutics Incorporated
corcept
суббота, 21 мая 2011 г.
Australian Researchers Halve Relapses In Bipolar Disorder
Melbourne mental health researchers have succeeded in halving the number of relapses experienced by people with bipolar disorder which strikes two in 100 Australians, accounts for 12 per cent of suicides each year and costs the country at least $1.5 billion annually(1).
With funding from the MBF Foundation and Beyond Blue, a team led by the Mental Health Research Institute of Victoria has developed an innovative structured group program to help people with bipolar disorder to better manage their condition.
The 12-session program, led by trained mental health clinicians, enables people battling the disorder to effectively monitor their mood, assess personal triggers and early warning signs of oncoming illness and take the necessary steps to stay well.
In a controlled randomised study of 84 people diagnosed with bipolar disorder, those on the special intervention program had half the number of relapses after 12 months as the control group which continued with normal treatment. Even with modern drug therapies that act as mood stabilisers, relapse rates for people with bipolar disorder are as high as 40 per cent in the first year and almost 75 per cent over five years.
MBF general manager health product, Michael Carafillis, said the new program provides a much-needed bridge between the mental health services that treat people when they are acutely ill and the GPs and private psychiatrists who provide ongoing care.
"Bipolar is a complicated disease involving periods of depression and mania and its sufferers don't always take their medications when they should," said Mr Carafillis.
"People with the condition straddle the divide between public and private systems resulting in poor continuity of care for many sufferers. They tend to gain access to the public system in the most severely disabling phase of their illness, typically mania, and are often too ill and the disorder too complex to be easily managed in primary care."
Professor David Castle at the Mental Health Research Institute of Victoria said providing people with bipolar disorder with the right tools and strategies to better self-manage their disease in a supportive group environment can substantially reduce the burden on individuals, their families and the health system.
Buoyed by the exciting results, the research team is now training clinicians in metropolitan and regional Victoria. The development of an accompanying service delivery framework, already being implemented in parts of Victoria, South Australia and the ACT, will enable the program to be rolled out in other states. (1) Access Economics report (2003) commissioned by SANE Australia
Source: Jackie Crossman
Research Australia
With funding from the MBF Foundation and Beyond Blue, a team led by the Mental Health Research Institute of Victoria has developed an innovative structured group program to help people with bipolar disorder to better manage their condition.
The 12-session program, led by trained mental health clinicians, enables people battling the disorder to effectively monitor their mood, assess personal triggers and early warning signs of oncoming illness and take the necessary steps to stay well.
In a controlled randomised study of 84 people diagnosed with bipolar disorder, those on the special intervention program had half the number of relapses after 12 months as the control group which continued with normal treatment. Even with modern drug therapies that act as mood stabilisers, relapse rates for people with bipolar disorder are as high as 40 per cent in the first year and almost 75 per cent over five years.
MBF general manager health product, Michael Carafillis, said the new program provides a much-needed bridge between the mental health services that treat people when they are acutely ill and the GPs and private psychiatrists who provide ongoing care.
"Bipolar is a complicated disease involving periods of depression and mania and its sufferers don't always take their medications when they should," said Mr Carafillis.
"People with the condition straddle the divide between public and private systems resulting in poor continuity of care for many sufferers. They tend to gain access to the public system in the most severely disabling phase of their illness, typically mania, and are often too ill and the disorder too complex to be easily managed in primary care."
Professor David Castle at the Mental Health Research Institute of Victoria said providing people with bipolar disorder with the right tools and strategies to better self-manage their disease in a supportive group environment can substantially reduce the burden on individuals, their families and the health system.
Buoyed by the exciting results, the research team is now training clinicians in metropolitan and regional Victoria. The development of an accompanying service delivery framework, already being implemented in parts of Victoria, South Australia and the ACT, will enable the program to be rolled out in other states. (1) Access Economics report (2003) commissioned by SANE Australia
Source: Jackie Crossman
Research Australia
пятница, 20 мая 2011 г.
Has Exercise Treatment A Role In Improving Mood Swings?
A paper that is published in the current issue of Psychotherapy and Psychosomatics analyzes the role of exercise treatment in mood swings.
Outcomes are frequently suboptimal for patients with bipolar disorder who are treated with pharmacotherapy alone. Adjunct exercise has the potential to substantially improve acute and long-term outcomes, although how exercise would improve the course of bipolar disorder needs to be elucidated. The Authors of this study propose that exercise may improve mood and functioning by increasing neurogenesis and reducing allostatic load. In this paper, they review data suggesting that exercise increases levels of brain-derived neurotrophic factor, which in turn increases neurogenesis and decreases allostatic load. Exercise as a psychosocial adjunct for bipolar disorder should be assessed with rigorous randomized clinical trials.
Source: Psychotherapy and Psychosomatics
Outcomes are frequently suboptimal for patients with bipolar disorder who are treated with pharmacotherapy alone. Adjunct exercise has the potential to substantially improve acute and long-term outcomes, although how exercise would improve the course of bipolar disorder needs to be elucidated. The Authors of this study propose that exercise may improve mood and functioning by increasing neurogenesis and reducing allostatic load. In this paper, they review data suggesting that exercise increases levels of brain-derived neurotrophic factor, which in turn increases neurogenesis and decreases allostatic load. Exercise as a psychosocial adjunct for bipolar disorder should be assessed with rigorous randomized clinical trials.
Source: Psychotherapy and Psychosomatics
четверг, 19 мая 2011 г.
New Seroquel data support benefits in bipolar disorder
New data presented today at the American Psychiatry Association (APA) meeting in Atlanta, USA, demonstrate that the
atypical antipsychotic SEROQUEL (Quetiapine) is effective in reducing suicidal thinking in patients suffering from bipolar
depression, and also improves quality of life and adherence to treatment in patients with bipolar disorder.
"Unfortunately bipolar depression is associated with high suicide rates, with 25% to 50% of people with the illness
attempting suicide " commented Professor Joseph Calabrese, Co-Director of the Bipolar Research Center at University Hospitals
of Cleveland and Case Western Reserve University School of Medicine. "These data suggest a brighter future for patients with
bipolar disorder as they illustrate that those treated with SEROQUEL benefit from a strong efficacy profile, combined with
improved compliance and quality of life - three factors in antipsychotic treatment that are intrinsically linked. The fact
that this strong efficacy profile includes an ability to reduce suicidal thinking is a significant benefit and is encouraging
news for clinicians who are striving to deliver meaningful results for their patients."
Reducing suicidal thinking key to reducing high suicide rates: These data, from the BOLDER (BipOLar DEpRession) trial1, an
eight week, multi-centre, randomised, double-blind, placebo-controlled study involving 542 patients with a diagnosis of
bipolar I or II disorder, showed that SEROQUEL (600 and 300 mg/day) is approximately twice as effective in reducing suicidal
ideation by week eight as placebo. The results were analysed using standard clinical scales to assess improvements in
depressive and anxiety symptoms. Additional results from the BOLDER study showed:
-- SEROQUEL (600 and 300 mg/day) significantly improved the core symptoms of depression as early as week one onwards
(symptoms include apparent sadness, reported sadness, inability to feel, suicidal thoughts, and pessimistic thoughts)
-- A significant improvement in anxiety symptoms occurred as early as week one and was maintained to study end (P
Improving quality of life and treatment adherence:
Bipolar depression is also associated with a significant impairment on patients' quality of life. Further new data from the
BOLDER trial2 presented at the APA meeting demonstrate a significant improvement in quality of life for patients with bipolar
depression who are treated with SEROQUEL (600 and 300 mg/day). Results were analysed using a 16-item questionnaire that
measures differences in the degree of enjoyment and satisfaction among groups of patients, as well as changes over time in a
single patient. Results showed:
-- SEROQUEL is effective in improving quality of life as demonstrated by the improvement in Q-LES-Q SF score which was
significantly greater in both SEROQUEL treatment groups (11.7 in the 600 mg/day group and 10.8 in the 300 mg/day group at
final assessment) than in the placebo group (6.4, p
atypical antipsychotic SEROQUEL (Quetiapine) is effective in reducing suicidal thinking in patients suffering from bipolar
depression, and also improves quality of life and adherence to treatment in patients with bipolar disorder.
"Unfortunately bipolar depression is associated with high suicide rates, with 25% to 50% of people with the illness
attempting suicide " commented Professor Joseph Calabrese, Co-Director of the Bipolar Research Center at University Hospitals
of Cleveland and Case Western Reserve University School of Medicine. "These data suggest a brighter future for patients with
bipolar disorder as they illustrate that those treated with SEROQUEL benefit from a strong efficacy profile, combined with
improved compliance and quality of life - three factors in antipsychotic treatment that are intrinsically linked. The fact
that this strong efficacy profile includes an ability to reduce suicidal thinking is a significant benefit and is encouraging
news for clinicians who are striving to deliver meaningful results for their patients."
Reducing suicidal thinking key to reducing high suicide rates: These data, from the BOLDER (BipOLar DEpRession) trial1, an
eight week, multi-centre, randomised, double-blind, placebo-controlled study involving 542 patients with a diagnosis of
bipolar I or II disorder, showed that SEROQUEL (600 and 300 mg/day) is approximately twice as effective in reducing suicidal
ideation by week eight as placebo. The results were analysed using standard clinical scales to assess improvements in
depressive and anxiety symptoms. Additional results from the BOLDER study showed:
-- SEROQUEL (600 and 300 mg/day) significantly improved the core symptoms of depression as early as week one onwards
(symptoms include apparent sadness, reported sadness, inability to feel, suicidal thoughts, and pessimistic thoughts)
-- A significant improvement in anxiety symptoms occurred as early as week one and was maintained to study end (P
Improving quality of life and treatment adherence:
Bipolar depression is also associated with a significant impairment on patients' quality of life. Further new data from the
BOLDER trial2 presented at the APA meeting demonstrate a significant improvement in quality of life for patients with bipolar
depression who are treated with SEROQUEL (600 and 300 mg/day). Results were analysed using a 16-item questionnaire that
measures differences in the degree of enjoyment and satisfaction among groups of patients, as well as changes over time in a
single patient. Results showed:
-- SEROQUEL is effective in improving quality of life as demonstrated by the improvement in Q-LES-Q SF score which was
significantly greater in both SEROQUEL treatment groups (11.7 in the 600 mg/day group and 10.8 in the 300 mg/day group at
final assessment) than in the placebo group (6.4, p
среда, 18 мая 2011 г.
Mental Health Foundation Welcomes New Health Guidance But Calls For A Holistic Approach For All, UK
In response to the 'Choosing Health: Supporting the physical health needs of people with severe mental illness' guidance published by the Department of Health, Andrew McCulloch, Chief Executive of the Mental Health Foundation, said;
"This is a welcome step in the right direction. We know that exercise and a balanced diet can maintain mental well-being. Good physical health is also important for people with severe mental health problems as they are more likely to develop serious physical ailments such as diabetes or heart disease.
"However, with mental ill-health costing the UK almost Ј100 billion a year*, it is imperative that the Government view this as a step on the way to improvement. They must continue to develop this holistic approach and include those with more moderate mental health problems. We know that, not only can these conditions present themselves as physical symptoms, but exercise is an effective treatment for mild to moderate depression."
* In the UK, the economic and social cost of mental health problems in 2003/2004 was Ј98 billion (Ј17billion on health and social care, Ј28.3 billion in costs to the economy and Ј53.1 billion in human costs). Fundamental Facts (unpublished). London: Mental Health Foundation 2006.
The Mental Health Foundation uses research and practical projects to help people survive, recover from and prevent mental health problems. We work to influence policy, including government at the highest levels. And we use our knowledge to raise awareness and to help tackle the stigma attached to mental illness. We reach millions of people every year through our media work, information booklets and online services.
mhf.uk
"This is a welcome step in the right direction. We know that exercise and a balanced diet can maintain mental well-being. Good physical health is also important for people with severe mental health problems as they are more likely to develop serious physical ailments such as diabetes or heart disease.
"However, with mental ill-health costing the UK almost Ј100 billion a year*, it is imperative that the Government view this as a step on the way to improvement. They must continue to develop this holistic approach and include those with more moderate mental health problems. We know that, not only can these conditions present themselves as physical symptoms, but exercise is an effective treatment for mild to moderate depression."
* In the UK, the economic and social cost of mental health problems in 2003/2004 was Ј98 billion (Ј17billion on health and social care, Ј28.3 billion in costs to the economy and Ј53.1 billion in human costs). Fundamental Facts (unpublished). London: Mental Health Foundation 2006.
The Mental Health Foundation uses research and practical projects to help people survive, recover from and prevent mental health problems. We work to influence policy, including government at the highest levels. And we use our knowledge to raise awareness and to help tackle the stigma attached to mental illness. We reach millions of people every year through our media work, information booklets and online services.
mhf.uk
вторник, 17 мая 2011 г.
For Bipolar Depression, Surveyed Experts Indicate That Current And Emerging Therapies Have No Advantage Over Seroquel In Decreasing The Syptoms
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed psychiatrists identify a therapy's effect on decrease in severity of depressive symptoms as the attribute that most influences their prescribing decisions in bipolar depression. Clinical data and the opinions of interviewed thought leaders indicate that current and emerging therapies have no advantage in this attribute over AstraZeneca's Seroquel, the sales-leading agent in the market.
The new report entitled Bipolar Depression: Despite Negative Results, Physicians Still Hopeful About Aripiprazole also finds that an oral therapy that carries a lower risk of weight gain than Seroquel would earn a 21 percent patient share in bipolar depression in the United States and a 30 percent patient share in Europe, according to surveyed U.S. and European psychiatrists. The report also finds that, despite the failure of Bristol-Myers Squibb/Otsuka Pharmaceutical's Abilify (aripiprazole) in bipolar depression clinical trials, most interviewed thought leaders believe that Abilify is still an efficacious therapy for bipolar depression.
In 2008, Decision Resources' proprietary clinical gold standard for bipolar depression was lamotrigine (GlaxoSmithKline's Lamictal, generics). Based on available data and expert opinion, lamotrigine will retain gold standard status through 2017. While some therapies in development for bipolar depression hold promise, most have efficacy, safety and tolerability, and/or delivery features that are inferior when compared with lamotrigine.
"Owing to its efficacy and tolerability advantages, lamotrigine edged out Seroquel, its closest competitor, to become the clinical gold standard," said Decision Resources Analyst Sandra Chow, M.Sc. "Despite its slow onset of action, interviewed thought leaders were particularly impressed with lamotrigine's side-effect profile and better evidence of efficacy as a long term mood stabilizer."
About the Report
Bipolar Depression: Despite Negative Results, Physicians Still Hopeful About Aripiprazole is a DecisionBase 2009 report. DecisionBase 2009 is a decision-support tool that provides in-depth analysis of unmet need, physician expectations of new therapies and commercial dynamics to help pharmaceutical companies optimize their investments in drug development.
The report can be purchased by contacting Decision Resources. Members of the media may request an interview with an analyst.
Source: Decision Resources
View drug information on Abilify; Lamictal; Seroquel.
The new report entitled Bipolar Depression: Despite Negative Results, Physicians Still Hopeful About Aripiprazole also finds that an oral therapy that carries a lower risk of weight gain than Seroquel would earn a 21 percent patient share in bipolar depression in the United States and a 30 percent patient share in Europe, according to surveyed U.S. and European psychiatrists. The report also finds that, despite the failure of Bristol-Myers Squibb/Otsuka Pharmaceutical's Abilify (aripiprazole) in bipolar depression clinical trials, most interviewed thought leaders believe that Abilify is still an efficacious therapy for bipolar depression.
In 2008, Decision Resources' proprietary clinical gold standard for bipolar depression was lamotrigine (GlaxoSmithKline's Lamictal, generics). Based on available data and expert opinion, lamotrigine will retain gold standard status through 2017. While some therapies in development for bipolar depression hold promise, most have efficacy, safety and tolerability, and/or delivery features that are inferior when compared with lamotrigine.
"Owing to its efficacy and tolerability advantages, lamotrigine edged out Seroquel, its closest competitor, to become the clinical gold standard," said Decision Resources Analyst Sandra Chow, M.Sc. "Despite its slow onset of action, interviewed thought leaders were particularly impressed with lamotrigine's side-effect profile and better evidence of efficacy as a long term mood stabilizer."
About the Report
Bipolar Depression: Despite Negative Results, Physicians Still Hopeful About Aripiprazole is a DecisionBase 2009 report. DecisionBase 2009 is a decision-support tool that provides in-depth analysis of unmet need, physician expectations of new therapies and commercial dynamics to help pharmaceutical companies optimize their investments in drug development.
The report can be purchased by contacting Decision Resources. Members of the media may request an interview with an analyst.
Source: Decision Resources
View drug information on Abilify; Lamictal; Seroquel.
понедельник, 16 мая 2011 г.
Tamoxifen Treats Manic Phase Of Bipolar Disorder
The medication tamoxifen, best known as a treatment for breast cancer, dramatically reduces symptoms of the manic phase of bipolar disorder more quickly than many standard medications for the mental illness, a new study shows. Researchers at the National Institutes of Health's National Institute of Mental Health (NIMH) who conducted the study also explained how: Tamoxifen blocks an enzyme called protein kinase C (PKC) that regulates activities in brain cells. The enzyme is thought to be over-active during the manic phase of bipolar disorder.
By pointing to PKC as a target for new medications, the study raises the possibility of developing faster-acting treatments for the manic phase of the illness. Current medications for the manic phase generally take more than a week to begin working, and not everyone responds to them. Tamoxifen itself might not become a treatment of choice, though, because it also blocks estrogen -- the property that makes it useful as a treatment for breast cancer -- and because it may cause endometrial cancer if taken over long periods of time. Currently, tamoxifen is approved by the Food and Drug Administration for treatment of some kinds of cancer and infertility, for example. It was used experimentally in this study because it both blocks PKC and is able to enter the brain.
Results of the study were published online in the September issue of Bipolar Disorders by Husseini K. Manji, MD, Carlos A. Zarate Jr., MD, and colleagues.
Almost 6 million American adults have bipolar disorder, whose symptoms can be disabling. They include profound mood swings, from depression to vastly overblown excitement, energy, and elation, often accompanied by severe irritability. Children also can develop the illness.
During the manic phase of bipolar disorder, patients are in "overdrive" and may throw themselves intensely into harmful behaviors they might not otherwise engage in. They might indulge in risky pleasure-seeking behaviors with potentially serious health consequences, for example, or lavish spending sprees they can't afford. The symptoms sometimes are severe enough to require hospitalization.
"People think of the depressive phase of this brain disorder as the time of risk, but the manic phase has its own dangers," said NIMH Director Thomas R. Insel, MD. "Being able to treat the manic phase more quickly would be a great asset to patients, not just for restoring balance in mood, but also because it could help stop harmful behaviors before they start or get out of control."
The three-week study included eight patients who were given tamoxifen and eight who were given a placebo (a sugar pill); all were adults and all were having a manic episode at the time of the study. Neither the patients nor the researchers knew which of the substances the patients were getting.
By the end of the study, 63 percent of the patients taking tamoxifen had reduced manic symptoms, compared with only 13 percent of those taking a placebo. Patients taking tamoxifen responded by the fifth day -- which corresponds with the amount of time needed to build up enough tamoxifen in the brain to dampen PKC activity.
The researchers decided to test tamoxifen's effects on the manic phase of bipolar disorder because standard medications used to treat this phase, specifically, are known to lower PKC activity -- but they do it through a roundabout biochemical route that takes time. Tamoxifen is known instead to block PKC directly. As the researchers suspected would happen, tamoxifen's direct actions on PKC resulted in much faster relief of manic symptoms, compared with some of the standard medications available today.
"We now have proof of principle. Our results show that targeting PKC directly, rather than through the trickle-down mechanisms of current medications, is a feasible strategy for developing faster-acting medications for mania," said Manji. "This is a major step toward developing new kinds of medications."
Findings from another recent NIMH study strengthen the results. This previous study showed that the risk of developing bipolar disorder is influenced by a variation in a gene called DGKH. The gene makes a PKC-regulating protein known to be active in the biochemical pathway through which standard medications for bipolar disorder exert their effects -- another sign that PKC is a promising direct target at which to aim new medications for the illness.
"Mania isn't just your average mood swing, where any of us might feel upbeat in response to something that happens. It's part of a brain disorder whose behavioral manifestations can severely undermine people's jobs, relationships, and health," said Zarate. "The sooner we can help patients get back on an even keel, the more we can help them avoid major disruptions to their lives and the lives of people around them."
For more information about bipolar disorder, visit the NIMH website at nimh.nih/healthinformation/bipolarmenu.cfm.
The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website: nimh.nih/.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.
Reference: Zarate Jr. CA, Singh JB, Carlson PJ, Quiroz J, Jolkovsky L, Luckenbaugh DA, Manji HK. Efficiency of a Protein Kinase C Inhibitor (Tamoxifen) in the Treatment of Acute Mania: A Pilot Study. Bipolar Disorders, online ahead of print, September 2007.
Source: Susan Cahill
NIH/National Institute of Mental Health
By pointing to PKC as a target for new medications, the study raises the possibility of developing faster-acting treatments for the manic phase of the illness. Current medications for the manic phase generally take more than a week to begin working, and not everyone responds to them. Tamoxifen itself might not become a treatment of choice, though, because it also blocks estrogen -- the property that makes it useful as a treatment for breast cancer -- and because it may cause endometrial cancer if taken over long periods of time. Currently, tamoxifen is approved by the Food and Drug Administration for treatment of some kinds of cancer and infertility, for example. It was used experimentally in this study because it both blocks PKC and is able to enter the brain.
Results of the study were published online in the September issue of Bipolar Disorders by Husseini K. Manji, MD, Carlos A. Zarate Jr., MD, and colleagues.
Almost 6 million American adults have bipolar disorder, whose symptoms can be disabling. They include profound mood swings, from depression to vastly overblown excitement, energy, and elation, often accompanied by severe irritability. Children also can develop the illness.
During the manic phase of bipolar disorder, patients are in "overdrive" and may throw themselves intensely into harmful behaviors they might not otherwise engage in. They might indulge in risky pleasure-seeking behaviors with potentially serious health consequences, for example, or lavish spending sprees they can't afford. The symptoms sometimes are severe enough to require hospitalization.
"People think of the depressive phase of this brain disorder as the time of risk, but the manic phase has its own dangers," said NIMH Director Thomas R. Insel, MD. "Being able to treat the manic phase more quickly would be a great asset to patients, not just for restoring balance in mood, but also because it could help stop harmful behaviors before they start or get out of control."
The three-week study included eight patients who were given tamoxifen and eight who were given a placebo (a sugar pill); all were adults and all were having a manic episode at the time of the study. Neither the patients nor the researchers knew which of the substances the patients were getting.
By the end of the study, 63 percent of the patients taking tamoxifen had reduced manic symptoms, compared with only 13 percent of those taking a placebo. Patients taking tamoxifen responded by the fifth day -- which corresponds with the amount of time needed to build up enough tamoxifen in the brain to dampen PKC activity.
The researchers decided to test tamoxifen's effects on the manic phase of bipolar disorder because standard medications used to treat this phase, specifically, are known to lower PKC activity -- but they do it through a roundabout biochemical route that takes time. Tamoxifen is known instead to block PKC directly. As the researchers suspected would happen, tamoxifen's direct actions on PKC resulted in much faster relief of manic symptoms, compared with some of the standard medications available today.
"We now have proof of principle. Our results show that targeting PKC directly, rather than through the trickle-down mechanisms of current medications, is a feasible strategy for developing faster-acting medications for mania," said Manji. "This is a major step toward developing new kinds of medications."
Findings from another recent NIMH study strengthen the results. This previous study showed that the risk of developing bipolar disorder is influenced by a variation in a gene called DGKH. The gene makes a PKC-regulating protein known to be active in the biochemical pathway through which standard medications for bipolar disorder exert their effects -- another sign that PKC is a promising direct target at which to aim new medications for the illness.
"Mania isn't just your average mood swing, where any of us might feel upbeat in response to something that happens. It's part of a brain disorder whose behavioral manifestations can severely undermine people's jobs, relationships, and health," said Zarate. "The sooner we can help patients get back on an even keel, the more we can help them avoid major disruptions to their lives and the lives of people around them."
For more information about bipolar disorder, visit the NIMH website at nimh.nih/healthinformation/bipolarmenu.cfm.
The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website: nimh.nih/.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.
Reference: Zarate Jr. CA, Singh JB, Carlson PJ, Quiroz J, Jolkovsky L, Luckenbaugh DA, Manji HK. Efficiency of a Protein Kinase C Inhibitor (Tamoxifen) in the Treatment of Acute Mania: A Pilot Study. Bipolar Disorders, online ahead of print, September 2007.
Source: Susan Cahill
NIH/National Institute of Mental Health
воскресенье, 15 мая 2011 г.
Common Causes Of Schizophrenia And Bipolar Disorder
Schizophrenia and bipolar disorder have the same genetic causes, according to a study from Karolinska Institutet published today in the highly respected journal The Lancet. The results throw the current separate classification of the diseases into question.
Schizophrenia and bipolar disorder (also known as manic-depressive illness) are the two most common psychotic disorders. For over a century, the two diseases have been treated as distinct by clinical practitioners and researchers as regards definitions and risk factors. However, such strict classification has met increasing scepticism over the years, partly owing to the results of modern genetic science, which has shown that certain genes seem to affect both disorders.
To study whether schizophrenia and bipolar disorder have the same genetic causes, Swedish scientists analysed the records of two million families, including 35,985 patients with schizophrenia, 40,487 patients with bipolar disorder, and the blood relatives of both.
Their results show that members of families in which someone has either schizophrenia or bipolar disorder run an increased risk of developing the same condition. The results also show that this is chiefly the result of genetic factors, and only slightly due to shared environmental factors. The scientists also found that patients with schizophrenia are also more prone to bipolar disorder, and that relatives of patients with one of the diseases are more likely to have relatives with the other.
According to the researchers, the results, taken as a whole, provide convincing proof that schizophrenia and bipolar disorder are very much hereditary diseases, and that they share, in part, a common genetic cause. They also argue that it is important for clinicians and researchers to take this common genetic background into account when studying and treating schizophrenia and bipolar disorder.
The study was funded by the Swedish Council for Working Life and Social Research and the Swedish Research Council.
Publication:
"Common genetic determinants of schizophrenia and bipolar disorder in Swedish families: a population-based study"
Paul Lichtenstein, Benjamin H Yip, Camilla Björk, Yudi Pawitan, Tyrone D Cannon, Patrick F Sullivan, Christina M Hultman
The Lancet, 16 January 2009
Download images: ki.se/pressimages
Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine.
Karolinska Institutet
Schizophrenia and bipolar disorder (also known as manic-depressive illness) are the two most common psychotic disorders. For over a century, the two diseases have been treated as distinct by clinical practitioners and researchers as regards definitions and risk factors. However, such strict classification has met increasing scepticism over the years, partly owing to the results of modern genetic science, which has shown that certain genes seem to affect both disorders.
To study whether schizophrenia and bipolar disorder have the same genetic causes, Swedish scientists analysed the records of two million families, including 35,985 patients with schizophrenia, 40,487 patients with bipolar disorder, and the blood relatives of both.
Their results show that members of families in which someone has either schizophrenia or bipolar disorder run an increased risk of developing the same condition. The results also show that this is chiefly the result of genetic factors, and only slightly due to shared environmental factors. The scientists also found that patients with schizophrenia are also more prone to bipolar disorder, and that relatives of patients with one of the diseases are more likely to have relatives with the other.
According to the researchers, the results, taken as a whole, provide convincing proof that schizophrenia and bipolar disorder are very much hereditary diseases, and that they share, in part, a common genetic cause. They also argue that it is important for clinicians and researchers to take this common genetic background into account when studying and treating schizophrenia and bipolar disorder.
The study was funded by the Swedish Council for Working Life and Social Research and the Swedish Research Council.
Publication:
"Common genetic determinants of schizophrenia and bipolar disorder in Swedish families: a population-based study"
Paul Lichtenstein, Benjamin H Yip, Camilla Björk, Yudi Pawitan, Tyrone D Cannon, Patrick F Sullivan, Christina M Hultman
The Lancet, 16 January 2009
Download images: ki.se/pressimages
Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine.
Karolinska Institutet
суббота, 14 мая 2011 г.
Neurological soft signs found in bipolar I patients
Study findings reveal that patients with bipolar I disorder have neurological soft signs (NSS), which reflect stable neurological abnormalities that are established at, or before, disease onset.
NSS, which refer to impairments in sensory integration, motor co-ordination, and the sequencing of complex motor acts, have already been found to be more prevalent in schizophrenic individuals than in their mentally healthy peers.
However, relatively few studies have looked for NSS in patients with bipolar I disorder, observe A Negash (Addis Ababa University, Ethiopia) and colleagues.
"Studying prevalence and patterns of NSS in bipolar I disorder might increase knowledge of the causal mechanisms, neuroanatomy, and pathogenesis of this specific disorder," they say.
Using the Neurological Evaluation Scale (NES), the researchers looked for NSS in 224, predominantly treatment naпve, bipolar I disorder patients, and in 78 mentally healthy control individuals.
To continue reading this article please go to the following web page of psychiatrysource
NSS, which refer to impairments in sensory integration, motor co-ordination, and the sequencing of complex motor acts, have already been found to be more prevalent in schizophrenic individuals than in their mentally healthy peers.
However, relatively few studies have looked for NSS in patients with bipolar I disorder, observe A Negash (Addis Ababa University, Ethiopia) and colleagues.
"Studying prevalence and patterns of NSS in bipolar I disorder might increase knowledge of the causal mechanisms, neuroanatomy, and pathogenesis of this specific disorder," they say.
Using the Neurological Evaluation Scale (NES), the researchers looked for NSS in 224, predominantly treatment naпve, bipolar I disorder patients, and in 78 mentally healthy control individuals.
To continue reading this article please go to the following web page of psychiatrysource
пятница, 13 мая 2011 г.
Maintaining Mental Health Key To Having A Happy, Healthy, Holiday Season
The upcoming holidays are known as
much for stress and anxiety as they are for joyful times with family and
friends. It is easy to get caught up in the holiday frenzy, but there's
never a more important time to remember to take care of your mental health.
For people diagnosed with mood disorders, such as depression, the
holidays can be even more difficult. Sue Bergeson, president of the
Depression and Bipolar Support Alliance (DBSA), the nation's largest
patient-run organization focusing on the most prevalent mental illnesses,
stresses the importance of sticking to treatment plans that are already in
place.
"Whether you're diagnosed with a mood disorder or not, it's really
important to maintain a focus on your mental health over the holidays,"
Bergeson said. "If you are living with a mood disorder, remember to stick
to your treatment plan and don't alter anything without checking with your
doctor or therapist first.
"If you're not diagnosed with a mood disorder but feel yourself
starting to become stressed out, it's really important to take some quality
time for yourself," Bergeson added. "But if you start feeling sad or
hopeless for a prolonged period, it's a good idea to seek professional
help."
According to Bergeson, you can maximize the holiday experience and
minimize stress and mental anguish by remembering to follow a few simple
tips.
-- Set reasonable expectations. Remember the spirit of the season. It's
not about who has the best decorated house or who can buy the most
gifts. You, along with your family and friends, will have a more
pleasant experience if you're not overextended.
-- Don't take on more than you can handle. If your to-do list becomes too
long, divide the tasks over the course of a week. One long list
suddenly looks shorter when there are only a couple of tasks to
complete each day.
-- Delegate tasks. You shouldn't be expected to do everything, so it's
okay to ask for help. Let the saying "many hands make little work" be
more than a cliche this year.
-- Schedule time alone. It doesn't have to be a lot of time. Fifteen
minutes of quiet time can be quite rejuvenating, particularly for
parents or in households where there's a lot of activity or company
from out-of-town. Make a cup of tea, go for a walk, or find somewhere
quiet to retreat. The sounds of silence will be music to your ears.
And for people living with mood disorders, these tips can prove to be
real life savers.
-- Be honest with family and friends about your moods. Make sure there's
someone you can talk to over the holidays. Don't be afraid of bringing
everyone down with your mood; your family and friends may be worried
about you, and you will all feel better if there's an open line of
communication. Once you vocalize your feelings to someone you trust,
you'll be better able to manage your moods.
-- Make support group meetings a priority. It's easy to let your normal
routine slip away, but if you attend a peer-run support group like
those run by DBSA and other organizations, be sure to maintain your
regular schedule of doing so. You'll not only be getting the support
you need, you'll be helping your peers as well.
With these tips in mind, people will be more likely to have a mentally
healthy and happy holiday season, says Bergeson. "The question you have to
ask yourself is, 'Can I afford not to take care of my own mental health now
or at any other stressful time?'"
For more information about depression and bipolar disorder, how the
affect your life, and how to cope, visit DBSAlliance or call
(800) 826-3632.
Depression and Bipolar Support Alliance
dbsalliance
much for stress and anxiety as they are for joyful times with family and
friends. It is easy to get caught up in the holiday frenzy, but there's
never a more important time to remember to take care of your mental health.
For people diagnosed with mood disorders, such as depression, the
holidays can be even more difficult. Sue Bergeson, president of the
Depression and Bipolar Support Alliance (DBSA), the nation's largest
patient-run organization focusing on the most prevalent mental illnesses,
stresses the importance of sticking to treatment plans that are already in
place.
"Whether you're diagnosed with a mood disorder or not, it's really
important to maintain a focus on your mental health over the holidays,"
Bergeson said. "If you are living with a mood disorder, remember to stick
to your treatment plan and don't alter anything without checking with your
doctor or therapist first.
"If you're not diagnosed with a mood disorder but feel yourself
starting to become stressed out, it's really important to take some quality
time for yourself," Bergeson added. "But if you start feeling sad or
hopeless for a prolonged period, it's a good idea to seek professional
help."
According to Bergeson, you can maximize the holiday experience and
minimize stress and mental anguish by remembering to follow a few simple
tips.
-- Set reasonable expectations. Remember the spirit of the season. It's
not about who has the best decorated house or who can buy the most
gifts. You, along with your family and friends, will have a more
pleasant experience if you're not overextended.
-- Don't take on more than you can handle. If your to-do list becomes too
long, divide the tasks over the course of a week. One long list
suddenly looks shorter when there are only a couple of tasks to
complete each day.
-- Delegate tasks. You shouldn't be expected to do everything, so it's
okay to ask for help. Let the saying "many hands make little work" be
more than a cliche this year.
-- Schedule time alone. It doesn't have to be a lot of time. Fifteen
minutes of quiet time can be quite rejuvenating, particularly for
parents or in households where there's a lot of activity or company
from out-of-town. Make a cup of tea, go for a walk, or find somewhere
quiet to retreat. The sounds of silence will be music to your ears.
And for people living with mood disorders, these tips can prove to be
real life savers.
-- Be honest with family and friends about your moods. Make sure there's
someone you can talk to over the holidays. Don't be afraid of bringing
everyone down with your mood; your family and friends may be worried
about you, and you will all feel better if there's an open line of
communication. Once you vocalize your feelings to someone you trust,
you'll be better able to manage your moods.
-- Make support group meetings a priority. It's easy to let your normal
routine slip away, but if you attend a peer-run support group like
those run by DBSA and other organizations, be sure to maintain your
regular schedule of doing so. You'll not only be getting the support
you need, you'll be helping your peers as well.
With these tips in mind, people will be more likely to have a mentally
healthy and happy holiday season, says Bergeson. "The question you have to
ask yourself is, 'Can I afford not to take care of my own mental health now
or at any other stressful time?'"
For more information about depression and bipolar disorder, how the
affect your life, and how to cope, visit DBSAlliance or call
(800) 826-3632.
Depression and Bipolar Support Alliance
dbsalliance
среда, 11 мая 2011 г.
New Reports Link Mental Ill-health To Changing Diets
As new figures show that mental ill-health is costing the UK almost Ј100 billion a year , evidence released today by the Mental Health Foundation and Sustain reveals that changes to the human diet in the last fifty years or so could be an important factor behind the major rise of mental ill-health in the UK.
A body of evidence linking the impact of diet on mood and behaviour has been growing for many years. Now scientific evidence, published today, reveals that food can have an immediate and lasting effect upon a person's mental health and behaviour because of the way it affects the structure and function of the brain .
Significant changes in the way food is produced and manufactured have not only reduced the amounts of essential fats, vitamins and minerals consumed, but have also disturbed the balance of nutrients in the foods eaten. The proliferation of industrialised farming has introduced pesticides and altered the body fat composition of animals due to the diets they are now fed. As a result, the population's intake of omega-3 fatty acids has decreased whilst the consumption of omega-6 fatty acids has increased. According to the research, this unequal intake combined with a lack of vitamins and minerals is associated with depression, concentration and memory problems.
At the same time, the UK population is consuming less nutritious, fresh produce and more saturated fats and sugars. According to the Mental Health Foundation and Sustain, new substances, such as pesticides, additives and trans-fats have also been introduced to the diet. These, alone and in combination, can prevent the brain from functioning effectively.
There have also been remarkable changes in the way that the population prepares and cooks food. The research shows that only 29 per cent of 15-24 year olds report eating a meal made from scratch every day, compared to 50 per cent of those aged over 65. It is also reported that a high proportion of younger people are eating insufficient amounts of fresh fruit and vegetables, instead eating unhealthy foods including ready meals and takeaways (US English = Takeouts).
Amino acids are vital to good mental health. Neurotransmitters in the brain are made from amino acids, many of which need to be derived from the diet. A deficiency in certain amino acids can lead to feelings of depression, apathy and leave a person feeling unmotivated and unable to relax.
The two charities assert that many nutrients can improve a person's mental health, and dietary changes may hold the key to combating specific mental health problems including depression, schizophrenia, attention deficit hyperactivity disorder, and Alzheimer's disease.
Dr Andrew McCulloch, Chief Executive of the Mental Health Foundation, says: ''We are well aware of the effect of diet upon our physical health, but we are only just beginning to understand how the brain, as an organ, is influenced by the nutrients it derives from the foods we eat, and how our diets have an impact on our mental health. This evidence raises a number of important questions and concerns for us all, but the knowledge gives individuals the power to make decisions that will benefit them and future generations. On a larger scale, our Government cannot ignore the growing burden of mental ill health in the UK and must look to nutrition as an option in helping people to manage their mental health problems. The potential rewards, in economic terms, and in terms of alleviating human suffering, are enormous.''
Courtney Van de Weyer, researcher on the Feeding Minds campaign at Sustain, added: "The good news is that the diet for a healthy mind is the same as the diet for a health body. The bad news is that, unless there is a radical overhaul of food and farming policies - particularly on fish - there won't be healthy and nutritious foods available in the future for people to eat."
The two charities have joined forces on the Feeding Minds campaign to raise awareness of the links between diet and mental health, and are asking Government to increase financial and political support for measures to ensure that sustainable supplies of a wide variety of nutrient-rich foods are available, affordable and attractive for people to obtain both now and in the future. They are also calling on the Government to incorporate the link between diet and mental health into all food-related policy and practice.
REPORT KEY FINDINGS
Food consumption
· Over the last 60 years there has been a 34 per cent decline in UK vegetable consumption with currently only 13 per cent of men and 15 per cent of women now eating at least five portions of fruit and vegetables per day.
· People in the UK eat 59 per cent less fish - the main source of omega 3 fatty acids - than they did 60 years ago.
Mental health
· Some foods damage the brain by releasing toxins or oxidants that harm healthy brain cells. There are many more nutrients that serve the brain without deception or damage, which can improve mood and mental well-being.
· A balanced mood and feelings of well being can be protected by ensuring that a diet provides adequate amounts of complex carbohydrates, essential fats, amino acids, vitamins and minerals and water.
· Research indicates that good nutritional intake may be linked to academic success. A number of studies report that providing children with breakfast improves their daily and long-term academic performance.
· Among some young offenders, diets supplemented with vitamins, minerals and essential fatty acids have resulted in significant and remarkable reductions in anti-social behaviour.
Mental health problems
· There is growing evidence that diet plays an important contributory role in specific mental health problems including Attention Deficit Hyperactivity Disorder (ADHD), depression, schizophrenia and Alzheimer's disease.
· The presentation of depression in the UK population has increased dramatically over recent decades and this has been accompanied by a decrease in the age of onset, with more cases being reported in children, adolescents and young adults.
· The incidence of schizophrenia is similar across the globe, although there are differences in outcomes between countries. This implies that environmental factors have some role in determining the duration and severity of symptoms, and the role that diet has to play is attracting increasing scientific interest.
· Alzheimer's disease has become more common in the past fifty years and is believed to be the result of a combination of factors, including the aging population, genetics and environmental factors. Growing epidemiological evidence suggests that diet may be one of those environmental factors with associations being reported between the occurrence of Alzheimer's and high saturated fat, consumption, and low vitamin and mineral consumption.
· Complementary mental health care services that focus on diet and nutrition report promising results, particularly among those who experience ADHD and depression. On the whole however, they are poorly funded and have received insufficient research attention to draw firm conclusions.
National opinion poll findings
· Women report eating healthy foods, including fresh vegetables, fruit or fruit juice and meals made from scratch, more often than men, who tend to eat more takeaways and ready meals.
· Younger people are more likely than older people to report daily mental health problems, as are those in social class DE, those on a lower income, those who are not in paid employment and those who are not married.
· Nearly two thirds of those who do not report daily mental health problems eat fresh fruit or fruit juice every day, compared with less than half of those who do report daily mental health problems. This pattern is similar for fresh vegetables and salad.
· Those who report some level of mental health problem also eat fewer healthy foods (fresh fruit and vegetables, organic foods and meals made from scratch) and more unhealthy foods (chips and crisps, chocolate, ready meals and takeaways).
· The Feeding Minds campaign comprises two reports - Feeding Minds: the impact of food on mental health has been written for stakeholders within the mental health sector. Changing Diets, Changing Minds: how food affects mental well-being and behaviour has been written for stakeholders in the food and farming sectors. Both reports are free and available to download from mentalhealth.uk/feedingminds and sustainweb
· A Web Guide providing recipes and nutritional advice to help people manage their mental well-being can be found at mentalhealth.uk/feedingminds
· To sign a petition to campaign for the Government to incorporate the link between diet and mental health into all food-related policy and practice, visit mentalhealth.uk/feedingminds
The Mental Health Foundation is the leading UK charity working to improve services for both people with mental health problems and people with learning disabilities. It is the only charity to fund and work with both service users and providers and plays an important role in funding research and new approaches to promotion, treatment and care.
Sustain: The alliance for better food and farming advocates food and agriculture policies and practices that enhance the health and welfare of people and animals, improve the working and living environment, enrich society and culture and promote equity. We represent around 100 national public interest organisations working at international, national, regional and local level.
A body of evidence linking the impact of diet on mood and behaviour has been growing for many years. Now scientific evidence, published today, reveals that food can have an immediate and lasting effect upon a person's mental health and behaviour because of the way it affects the structure and function of the brain .
Significant changes in the way food is produced and manufactured have not only reduced the amounts of essential fats, vitamins and minerals consumed, but have also disturbed the balance of nutrients in the foods eaten. The proliferation of industrialised farming has introduced pesticides and altered the body fat composition of animals due to the diets they are now fed. As a result, the population's intake of omega-3 fatty acids has decreased whilst the consumption of omega-6 fatty acids has increased. According to the research, this unequal intake combined with a lack of vitamins and minerals is associated with depression, concentration and memory problems.
At the same time, the UK population is consuming less nutritious, fresh produce and more saturated fats and sugars. According to the Mental Health Foundation and Sustain, new substances, such as pesticides, additives and trans-fats have also been introduced to the diet. These, alone and in combination, can prevent the brain from functioning effectively.
There have also been remarkable changes in the way that the population prepares and cooks food. The research shows that only 29 per cent of 15-24 year olds report eating a meal made from scratch every day, compared to 50 per cent of those aged over 65. It is also reported that a high proportion of younger people are eating insufficient amounts of fresh fruit and vegetables, instead eating unhealthy foods including ready meals and takeaways (US English = Takeouts).
Amino acids are vital to good mental health. Neurotransmitters in the brain are made from amino acids, many of which need to be derived from the diet. A deficiency in certain amino acids can lead to feelings of depression, apathy and leave a person feeling unmotivated and unable to relax.
The two charities assert that many nutrients can improve a person's mental health, and dietary changes may hold the key to combating specific mental health problems including depression, schizophrenia, attention deficit hyperactivity disorder, and Alzheimer's disease.
Dr Andrew McCulloch, Chief Executive of the Mental Health Foundation, says: ''We are well aware of the effect of diet upon our physical health, but we are only just beginning to understand how the brain, as an organ, is influenced by the nutrients it derives from the foods we eat, and how our diets have an impact on our mental health. This evidence raises a number of important questions and concerns for us all, but the knowledge gives individuals the power to make decisions that will benefit them and future generations. On a larger scale, our Government cannot ignore the growing burden of mental ill health in the UK and must look to nutrition as an option in helping people to manage their mental health problems. The potential rewards, in economic terms, and in terms of alleviating human suffering, are enormous.''
Courtney Van de Weyer, researcher on the Feeding Minds campaign at Sustain, added: "The good news is that the diet for a healthy mind is the same as the diet for a health body. The bad news is that, unless there is a radical overhaul of food and farming policies - particularly on fish - there won't be healthy and nutritious foods available in the future for people to eat."
The two charities have joined forces on the Feeding Minds campaign to raise awareness of the links between diet and mental health, and are asking Government to increase financial and political support for measures to ensure that sustainable supplies of a wide variety of nutrient-rich foods are available, affordable and attractive for people to obtain both now and in the future. They are also calling on the Government to incorporate the link between diet and mental health into all food-related policy and practice.
REPORT KEY FINDINGS
Food consumption
· Over the last 60 years there has been a 34 per cent decline in UK vegetable consumption with currently only 13 per cent of men and 15 per cent of women now eating at least five portions of fruit and vegetables per day.
· People in the UK eat 59 per cent less fish - the main source of omega 3 fatty acids - than they did 60 years ago.
Mental health
· Some foods damage the brain by releasing toxins or oxidants that harm healthy brain cells. There are many more nutrients that serve the brain without deception or damage, which can improve mood and mental well-being.
· A balanced mood and feelings of well being can be protected by ensuring that a diet provides adequate amounts of complex carbohydrates, essential fats, amino acids, vitamins and minerals and water.
· Research indicates that good nutritional intake may be linked to academic success. A number of studies report that providing children with breakfast improves their daily and long-term academic performance.
· Among some young offenders, diets supplemented with vitamins, minerals and essential fatty acids have resulted in significant and remarkable reductions in anti-social behaviour.
Mental health problems
· There is growing evidence that diet plays an important contributory role in specific mental health problems including Attention Deficit Hyperactivity Disorder (ADHD), depression, schizophrenia and Alzheimer's disease.
· The presentation of depression in the UK population has increased dramatically over recent decades and this has been accompanied by a decrease in the age of onset, with more cases being reported in children, adolescents and young adults.
· The incidence of schizophrenia is similar across the globe, although there are differences in outcomes between countries. This implies that environmental factors have some role in determining the duration and severity of symptoms, and the role that diet has to play is attracting increasing scientific interest.
· Alzheimer's disease has become more common in the past fifty years and is believed to be the result of a combination of factors, including the aging population, genetics and environmental factors. Growing epidemiological evidence suggests that diet may be one of those environmental factors with associations being reported between the occurrence of Alzheimer's and high saturated fat, consumption, and low vitamin and mineral consumption.
· Complementary mental health care services that focus on diet and nutrition report promising results, particularly among those who experience ADHD and depression. On the whole however, they are poorly funded and have received insufficient research attention to draw firm conclusions.
National opinion poll findings
· Women report eating healthy foods, including fresh vegetables, fruit or fruit juice and meals made from scratch, more often than men, who tend to eat more takeaways and ready meals.
· Younger people are more likely than older people to report daily mental health problems, as are those in social class DE, those on a lower income, those who are not in paid employment and those who are not married.
· Nearly two thirds of those who do not report daily mental health problems eat fresh fruit or fruit juice every day, compared with less than half of those who do report daily mental health problems. This pattern is similar for fresh vegetables and salad.
· Those who report some level of mental health problem also eat fewer healthy foods (fresh fruit and vegetables, organic foods and meals made from scratch) and more unhealthy foods (chips and crisps, chocolate, ready meals and takeaways).
· The Feeding Minds campaign comprises two reports - Feeding Minds: the impact of food on mental health has been written for stakeholders within the mental health sector. Changing Diets, Changing Minds: how food affects mental well-being and behaviour has been written for stakeholders in the food and farming sectors. Both reports are free and available to download from mentalhealth.uk/feedingminds and sustainweb
· A Web Guide providing recipes and nutritional advice to help people manage their mental well-being can be found at mentalhealth.uk/feedingminds
· To sign a petition to campaign for the Government to incorporate the link between diet and mental health into all food-related policy and practice, visit mentalhealth.uk/feedingminds
The Mental Health Foundation is the leading UK charity working to improve services for both people with mental health problems and people with learning disabilities. It is the only charity to fund and work with both service users and providers and plays an important role in funding research and new approaches to promotion, treatment and care.
Sustain: The alliance for better food and farming advocates food and agriculture policies and practices that enhance the health and welfare of people and animals, improve the working and living environment, enrich society and culture and promote equity. We represent around 100 national public interest organisations working at international, national, regional and local level.
вторник, 10 мая 2011 г.
Landmark STAR*D Depression Study Offers 'Sobering' Third-Round Results
New results of the nation's largest depression study show that patients who have already failed on two prior antidepressants and then switch to a different class of antidepressants have only a minimal chance at remission by making the switch. The finding is part of the third wave of reports from the "Sequenced Treatment Alternatives to Relieve Depression" (STAR*D) study and is being released in the July 2006 issue of The American Journal of Psychiatry (AJP), the official journal of the American Psychiatric Association (APA).
The AJP article is entitled "A Comparison of Mirtazapine and Nortriptyline Following Two Consecutive Failed Medication Treatments for Depressed Outpatients: A STAR*D Report" and is by Maurizio Fava, M.D., of Massachusetts General Hospital.
In this trial, the 235 patients who opted for a switch in their medications were randomly assigned to nortriptyline or mirtazapine, antidepressants they had not taken in Level 1 or 2. The rates of remission after 14 weeks were 20 percent for nortriptyline and 12 percent for mirtazapine, but the difference was not considered statistically significant. The frequencies of adverse side effects were also similar.
"The results of STAR*D continue to be sobering. By the third wave of the study, the rate of remission continues to be quite low, which underscores the persistence of depression and its resistance to current treatments," states Robert Freedman, M.D., AJP editor-in-chief.
STAR*D was designed to parallel real-world practice. After the failure of the first one or two medications, often the clinician tries an antidepressant from a different pharmacological class. The antidepressants in Level 3 had pharmacological actions different from those in the previous levels and from each other.
"This finding is particularly relevant to clinical practice because it is based on typical patients," said Darrel A. Regier, M.D., M.P.H., director of the APA's Division of Research. "The scope and design of this large National Institute of Mental Health study makes it a welcome addition to evidence-based treatment in an effort to guide clinical practice."
"STAR*D is a laudable endeavor," comments Matthew Menza, M.D., of the Robert Wood Johnson Medical School in an accompanying editorial. "The study is the largest randomized clinical trial in depression ever conducted, and it is very well designed. The enrollment was efficient and included a large number of minorities, which is a rarity in clinical trials."
This study was funded by the National Institute of Mental Health. Medications for the STAR*D trials were provided at no cost by Bristol-Myers Squibb, Forest Pharmaceuticals, GlaxoSmithKline, King Pharmaceuticals, Organon, Pfizer, and Wyeth-Ayerst Laboratories.
(Am J Psychiatry. 2006; 163: 1161-1172).
Results from STAR*D Level 3 Augmentation Treatment Step to be reported in an upcoming American Journal of Psychiatry issue.
Earlier STAR*D results were reported in the following:
American Journal of Psychiatry 2006; 163:28-40, January 2006
New England Journal of Medicine 2006; 354:1231-1242, March 23, 2006
New England Journal of Medicine 2006; 354:1243-1252, March 23, 2006
About The American Journal of Psychiatry
The American Journal of Psychiatry, the official journal of the American Psychiatric Association, publishes a monthly issue with scientific articles submitted by psychiatrists and other scientists worldwide. The peer review and editing process is conducted independently of any other American Psychiatric Association components. Therefore, statements in this press release or the articles in the Journal are not official policy statements of the American Psychiatric Association. The Journal's editorial policies conform to the Uniform Requirements of the International Committee of Medical Journal Editors, of which it is a member.
For further information about the Journal visit ajp.psychiatryonline.
About the American Psychiatric Association
The American Psychiatric Association is a national medical specialty society whose more than 36,000 physician members specialize in diagnosis, treatment, prevention and research of mental illnesses including substance use disorders.
Visit the APA at psych and HealthyMinds.
The AJP article is entitled "A Comparison of Mirtazapine and Nortriptyline Following Two Consecutive Failed Medication Treatments for Depressed Outpatients: A STAR*D Report" and is by Maurizio Fava, M.D., of Massachusetts General Hospital.
In this trial, the 235 patients who opted for a switch in their medications were randomly assigned to nortriptyline or mirtazapine, antidepressants they had not taken in Level 1 or 2. The rates of remission after 14 weeks were 20 percent for nortriptyline and 12 percent for mirtazapine, but the difference was not considered statistically significant. The frequencies of adverse side effects were also similar.
"The results of STAR*D continue to be sobering. By the third wave of the study, the rate of remission continues to be quite low, which underscores the persistence of depression and its resistance to current treatments," states Robert Freedman, M.D., AJP editor-in-chief.
STAR*D was designed to parallel real-world practice. After the failure of the first one or two medications, often the clinician tries an antidepressant from a different pharmacological class. The antidepressants in Level 3 had pharmacological actions different from those in the previous levels and from each other.
"This finding is particularly relevant to clinical practice because it is based on typical patients," said Darrel A. Regier, M.D., M.P.H., director of the APA's Division of Research. "The scope and design of this large National Institute of Mental Health study makes it a welcome addition to evidence-based treatment in an effort to guide clinical practice."
"STAR*D is a laudable endeavor," comments Matthew Menza, M.D., of the Robert Wood Johnson Medical School in an accompanying editorial. "The study is the largest randomized clinical trial in depression ever conducted, and it is very well designed. The enrollment was efficient and included a large number of minorities, which is a rarity in clinical trials."
This study was funded by the National Institute of Mental Health. Medications for the STAR*D trials were provided at no cost by Bristol-Myers Squibb, Forest Pharmaceuticals, GlaxoSmithKline, King Pharmaceuticals, Organon, Pfizer, and Wyeth-Ayerst Laboratories.
(Am J Psychiatry. 2006; 163: 1161-1172).
Results from STAR*D Level 3 Augmentation Treatment Step to be reported in an upcoming American Journal of Psychiatry issue.
Earlier STAR*D results were reported in the following:
American Journal of Psychiatry 2006; 163:28-40, January 2006
New England Journal of Medicine 2006; 354:1231-1242, March 23, 2006
New England Journal of Medicine 2006; 354:1243-1252, March 23, 2006
About The American Journal of Psychiatry
The American Journal of Psychiatry, the official journal of the American Psychiatric Association, publishes a monthly issue with scientific articles submitted by psychiatrists and other scientists worldwide. The peer review and editing process is conducted independently of any other American Psychiatric Association components. Therefore, statements in this press release or the articles in the Journal are not official policy statements of the American Psychiatric Association. The Journal's editorial policies conform to the Uniform Requirements of the International Committee of Medical Journal Editors, of which it is a member.
For further information about the Journal visit ajp.psychiatryonline.
About the American Psychiatric Association
The American Psychiatric Association is a national medical specialty society whose more than 36,000 physician members specialize in diagnosis, treatment, prevention and research of mental illnesses including substance use disorders.
Visit the APA at psych and HealthyMinds.
понедельник, 9 мая 2011 г.
Major Geriatric Bipolar Disorder Study Now Under Way
Until now, there has been little research on the best ways to care for geriatric patients with bipolar disorder. Now, a major National Institute of Mental Health (NIMH)-funded multi-site clinical research study -- led by the Weill Cornell Institute of Geriatric Psychiatry at NewYork-Presbyterian Hospital/Westchester Division -- is the first to compare the efficacy of two commonly used mood stabilizers for geriatric patients suffering from the episodes of symptoms that characterize bipolar disorder, formerly known as manic-depressive illness.
Participating in the ongoing study are patients aged 60 and older whose bipolar disorder has been treated with carefully monitored dosages of either lithium or valproate. To date, more than 80 patients at six study sites, including 19 at NewYork-Presbyterian/Westchester, have participated. To address some of the barriers faced by the elderly in need of treatment, the Weill Cornell Institute of Geriatric Psychiatry is reaching out to the community. There is no cost for participating and, if needed, free transportation to the campus may be provided.
Known as Geri-BD (Geriatric Bipolar Disorder), the NIMH study is being led by Dr. Robert C. Young, a professor of psychiatry at Weill Cornell Medical College with more than 30 years of clinical and research experience, and his colleagues at the Institute. Dr. Young's focus has been the development of information to improve the pharmacological management of elders suffering severe mood disorders.
Dr. Young notes that the Geri-BD study is intended to fill a gap, noting that "evidence-based guidelines for older bipolar patients are critically needed, given the increase in the over-60 age group." About 10 million Americans -- or approximately 3.3 percent of the total population -- have been diagnosed with bipolar disorder. The American Psychiatric Association estimates that the number of elderly patients with bipolar disorder will grow significantly over the next few decades.
Dr. Young adds: "To date, most bipolar disorder treatment studies have been conducted in younger patients. However, in some aged bipolar patients, a good symptom response is difficult to achieve, and the mortality rate in elder bipolar patients is relatively high. We hope that findings from this study will help physicians better manage the care of their geriatric bipolar patients."
Bipolar disorder involves periods of elevated mood -- mania or hypomania -- and periods of depression or "mixed" episodes in which patients have both kinds of symptoms. Examples of manic symptoms are high levels of energy, going without sleep for extended periods, elated mood or irritability, and impulsive or reckless behavior. Patients may not recognize that they are having symptoms. "Another problem is that although there can be extended periods of normal mood, particularly with treatment, most people with bipolar disorder suffer from recurring symptom episodes," says Dr. Young.
Over the course of this nine-week study, Geri-BD participants are closely monitored by a psychiatrist who checks their mood state at each visit, assesses any side effects and measures the level of medication in their blood. "We're finding that studying older adults with bipolar disorder under standardized treatment is feasible and can be well tolerated," Dr. Young explains.
Individuals over 60 wishing to participate in the bipolar disorder research study at the Weill Cornell Institute of Geriatric Psychiatry located on the NewYork-Presbyterian Hospital White Plains campus are advised to call (914) 997-4331 or (800) NYP-1902 for a free, confidential bipolar screening. Candidates may qualify if they have experienced an increase in energy or a reduced need for sleep, or have been extremely irritable or feeling "on top of the world," or have been previously diagnosed with manic depression or bipolar disorder.
NewYork-Presbyterian/Westchester and five other research sites throughout the U.S. have been participating in the investigation since 2005: University of Pennsylvania, University of Pittsburgh, Case Western Reserve University, Duke University and Baylor College of Medicine.
NewYork-Presbyterian Hospital/Westchester Division
NewYork-Presbyterian Hospital/Westchester Division, opened in 1894, is one of the world's most advanced centers for psychiatric care. The Westchester Division serves children, adolescents, adults and the elderly with comprehensive outpatient, day treatment, partial hospitalization and inpatient services. In addition to clinical treatment, the Westchester Division is also a center for interdisciplinary medical research and education through its academic affiliate, Weill Cornell Medical College. NewYork-Presbyterian is one of the nation's top hospitals for psychiatry, as rated by U.S.News & World Report. For more information, visit nyp.
Participating in the ongoing study are patients aged 60 and older whose bipolar disorder has been treated with carefully monitored dosages of either lithium or valproate. To date, more than 80 patients at six study sites, including 19 at NewYork-Presbyterian/Westchester, have participated. To address some of the barriers faced by the elderly in need of treatment, the Weill Cornell Institute of Geriatric Psychiatry is reaching out to the community. There is no cost for participating and, if needed, free transportation to the campus may be provided.
Known as Geri-BD (Geriatric Bipolar Disorder), the NIMH study is being led by Dr. Robert C. Young, a professor of psychiatry at Weill Cornell Medical College with more than 30 years of clinical and research experience, and his colleagues at the Institute. Dr. Young's focus has been the development of information to improve the pharmacological management of elders suffering severe mood disorders.
Dr. Young notes that the Geri-BD study is intended to fill a gap, noting that "evidence-based guidelines for older bipolar patients are critically needed, given the increase in the over-60 age group." About 10 million Americans -- or approximately 3.3 percent of the total population -- have been diagnosed with bipolar disorder. The American Psychiatric Association estimates that the number of elderly patients with bipolar disorder will grow significantly over the next few decades.
Dr. Young adds: "To date, most bipolar disorder treatment studies have been conducted in younger patients. However, in some aged bipolar patients, a good symptom response is difficult to achieve, and the mortality rate in elder bipolar patients is relatively high. We hope that findings from this study will help physicians better manage the care of their geriatric bipolar patients."
Bipolar disorder involves periods of elevated mood -- mania or hypomania -- and periods of depression or "mixed" episodes in which patients have both kinds of symptoms. Examples of manic symptoms are high levels of energy, going without sleep for extended periods, elated mood or irritability, and impulsive or reckless behavior. Patients may not recognize that they are having symptoms. "Another problem is that although there can be extended periods of normal mood, particularly with treatment, most people with bipolar disorder suffer from recurring symptom episodes," says Dr. Young.
Over the course of this nine-week study, Geri-BD participants are closely monitored by a psychiatrist who checks their mood state at each visit, assesses any side effects and measures the level of medication in their blood. "We're finding that studying older adults with bipolar disorder under standardized treatment is feasible and can be well tolerated," Dr. Young explains.
Individuals over 60 wishing to participate in the bipolar disorder research study at the Weill Cornell Institute of Geriatric Psychiatry located on the NewYork-Presbyterian Hospital White Plains campus are advised to call (914) 997-4331 or (800) NYP-1902 for a free, confidential bipolar screening. Candidates may qualify if they have experienced an increase in energy or a reduced need for sleep, or have been extremely irritable or feeling "on top of the world," or have been previously diagnosed with manic depression or bipolar disorder.
NewYork-Presbyterian/Westchester and five other research sites throughout the U.S. have been participating in the investigation since 2005: University of Pennsylvania, University of Pittsburgh, Case Western Reserve University, Duke University and Baylor College of Medicine.
NewYork-Presbyterian Hospital/Westchester Division
NewYork-Presbyterian Hospital/Westchester Division, opened in 1894, is one of the world's most advanced centers for psychiatric care. The Westchester Division serves children, adolescents, adults and the elderly with comprehensive outpatient, day treatment, partial hospitalization and inpatient services. In addition to clinical treatment, the Westchester Division is also a center for interdisciplinary medical research and education through its academic affiliate, Weill Cornell Medical College. NewYork-Presbyterian is one of the nation's top hospitals for psychiatry, as rated by U.S.News & World Report. For more information, visit nyp.
воскресенье, 8 мая 2011 г.
Bipolar Disorder: Psychiatrists Are Taking A New Approach That Aims To Treat Not Just Symptoms But The Whole Person
Bipolar disorder is the name now used to describe Manic Depression - the condition where mood veers between two poles or extremes - one of euphoria (mania) and the other of despair (depression). Most of us know of it - if only because of famous sufferers such as Vincent van Gogh - but although bipolar disorder is as common as diabetes, much of it goes unrecognised and inadequately treated. This is a pity because there are now good treatments available that can help keep the condition under control and, to a large extent, allow individuals to carry on normally.
Official estimates say bipolar illness affects 1 to 4 per cent of the population but some researchers believe the real figure is closer to 10 per cent (1). The World Health Organization says it is already the sixth leading cause of disability (2).
There are two main types of bipolar disorder. People who have bipolar I will have experienced at least one severe episode of heightened mood or mania lasting a week, or a mix of manic and depressed symptoms. People with bipolar II will have experienced at least one major depression and some degree of mania although this may be much less severe than in bipolar I and is described as hypomania (3).
In severe cases of bipolar I mania, symptoms can take the form of delusions and hallucinations so must be treated promptly, usually in hospital. More usually, symptoms of mania and hypomania are less obvious; feelings of euphoria, grandiosity, impulsivity, recklessness, and a diminished need for sleep can be ascribed to youthful exuberance. At the depressive end of the spectrum, feelings of anxiety, irritability, hostility and depression can lead to violent or suicidal behaviour. Around one third of uncontrolled bipolar sufferers currently attempt suicide and about half of those succeed (4, 5).
Bipolar disorder typically makes itself felt in a person's late teens or early twenties. Men are just as likely to be affected as women. In nine out of ten cases it recurs periodically throughout life with an average of nine severe episodes over a course of about 20 years (6, 7). The ratio of depressive to manic episodes is greater than two to one in western populations. Compared with mania, episodes of depression also last much longer and carry a higher risk of suicide. Between episodes, sufferers can experience periods of relative calm and stability, with only normal mood variation, or minor symptoms. Today's treatments are geared to maintaining that state and, if or when symptoms erupt, to halting that process.
Diagnosis is difficult
The illness is complex and variable making it difficult for doctors to diagnose. All too often behaviours are marked down to a quirky personality or troubled adolescence. But bipolar disorder has nothing to do with personality, stresses Professor Allan Young, a prominent researcher in the field from University of British Columbia, Vancouver, Canada. "Early diagnosis and treatment are important because the condition impacts on so many aspects of a person's life," he emphasises.
"Unfortunately, bipolar disorder sufferers are more susceptible to anxiety which can adversely impact physical health and wellbeing," Professor Young adds. "There's also a strong risk of them abusing alcohol or other substances."
Misdiagnosis can be a problem as well as no diagnosis. "If bipolar sufferers are misdiagnosed as having only depression or anxiety and are treated with antidepressant drugs alone, there's a high risk of deteriorating", explains Professor Young. Similarly, treatment directed primarily at controlling and preventing mania, or efforts focussed on stopping substance abuse, can fail to tackle depressive symptoms.
Bipolar disorder sufferers are often highly intelligent and creative individuals. History reveals several, such as Charles Dickens and Beethoven, who used their bursts of manic energy to accomplish great achievements. But inability to keep the disorder in check can make it difficult for lesser mortals to hold down jobs and perform consistently well at work (8). Recent US research estimates that bipolar disorder costs the country over $14 billion dollars per year in lost productivity (9).
Bipolar disorder takes a heavy toll on the mind's ability to think, remember and reason normally, Professor Young points out (10). Not just through racing thoughts, lack of sleep, inattentiveness and impaired concentration, but also in more subtle, ways, collectively described as loss of 'executive functioning'. "This includes the ability to plan, dealing with emotions, organise, focus attention where needed, process information and access working memory" he explained. "It's the sort of thing we all take for granted but losing it can be terribly disabling for a bipolar patient."
It can also lead to breakdown of relationships. Bipolar patients are twice as likely to divorce compared to the general population (114). Bipolar mood swings also have repercussions on social life if resulting behaviours upset colleagues and friends as well as partners. Even close family members can sometimes find bipolar behaviours impossible to tolerate. That's probably the most compelling reason for getting bipolar disorder under control. Morbidity and mortality rates are higher in patients with bipolar disorder than they are for those patients suffering from cancer or cardiovascular disease.
Treatment has advanced
When sufferers do get diagnosed and treated - a process that can take up to 10 years - the type of treatment prescribed can vary and some may cause troublesome side effects.
Some older treatments cause so many problems that patients stop taking medication altogether, says psychiatrist Dr Heinz Grunze of Ludwig-Maximilians-University, Munich, Germany. Many patients have been expected to take up to four types of drugs daily, including several with unpleasant side effects (12, 13).
The former mainstay of bipolar treatment was the mood-stabilising therapy lithium. This is highly effective at controlling mania and is used as a maintenance therapy between episodes, as is the anticonvulsant valproate, but these drugs are now considered much less effective in preventing and controlling depressive symptoms and are less widely used (14). Patients receiving lithium need their blood monitoring and can experience side effects such as problems with thinking and memory, weight gain, and tremor that lead many to abandon treatment.
Psychiatrists believe treatment has advanced considerably over the past decade. Several effective new drugs for rapidly controlling mania are now available that can be used instead of, or to allow a reduction of, lithium, Professor Young explains: "Newer antipsychotic drugs, can control mania quickly without so many of the unwelcome side effects associated with older drugs (,15). In particular, it is the uncontrolled jerking or writhing movements that older drugs can cause that are so distressing and stigmatising."
Need for " whole person" treatment
"Doctors are now realising we need to look at patients in a wider sense than before," suggests Professor Young. Traditionally, doctors focussed on mania and depression and only judged drugs on how well they reduced these symptoms. Now they are realising how severely bipolar illness impacts on many aspects of life and acknowledge a need to assess drugs from other perspectives too (16). Side effects, including effects on weight and intellectual function, quality of life, ability to mix well with other people and whether or not a drug produces any consistent troubling minor symptoms are also important. "It is these kind of assessments that can better highlight when treatment is falling short of providing a remedy for the patient as a whole," he comments. Only when every domain of bipolar illness is addressed and doctors get the treatment right will patients get the best chance of fully recovering their ability to participate in normal life.
"What gets you well, keeps you well"
In the past, treatment of acute episodes of mania or depression were followed by a different mood-stabiliser therapy, notes Dr Grunze. The view now is that the treatment that gets you over the worst symptoms will also prevent them recurring. "What gets you well, keeps you well."
The fewer drugs a patient needs to take, the greater is the likelihood they will stick to treatment and take medication as directed. If one medicine is not sufficient, there may be alternatives to adding more drugs to treatment, argue patient groups. Talking therapies are also key, they believe, as is "psycho-education" (17, 18, 19). This is the process of learning to understand the nature of bipolar disorder and the importance of seeking help early when symptoms arise or get worse. It explains when and why medicines must be taken regularly, and teaches ways to cope. By avoiding destabilising triggers such as stress, overwork, and too little sleep, patients can help prevent acute episodes of mania and depression.
The new approach is to manage bipolar illness across all four dimensions - its impact on body, mind, emotions and social life. This means using both the effective medications and the non-drug interventions described above. If adopted by the majority of psychiatrists there is cause for optimism. New research, new thinking and new medicines should help revolutionise the prospects for bipolar patients restoring their life chances.
Mania signs
-- irritability
-- sleeping less without tiring
-- experiencing a rush of energy
-- uncontrolled spending
-- feeling more self-confident than usual
-- socialising/partying out of character
-- talking fast and more than usual
-- disjointed racing thoughts and ideas
-- difficulty concentrating
-- increased desire for sex
-- uncharacteristic reckless behaviour
Depression symptoms
-- prolonged sadness/crying
-- change in appetite: eating more/less
-- sleeping more than usual
-- loss of pleasure in usual interests
-- social withdrawal
-- feelings of worthlessness
-- suicidal thoughts
-- irritability, anger, anxiety
-- negativity and indifference
-- loss of energy/tiredness
References
1. Hirschfeld RM, Calabrese JR, Weissman MM et al. Screening for bipolar disorder in the community. J Clin Psychiatry 2003;64:53-59
2. World Health Organisation. The Global Burden of Disease summary. Harvard University Press. Cambridge. Mass 1996.
3. American Psychiatric Association. Diagnostic and statistics manual of mental disorders (DSM-IV-TR) 4th ed. 3rd rev. Washington DC. American Psychiat. Assoc 2000.
4. Angst F, Stassen HH, Clayton PJ et al. Mortality of patients with mood disorders: follow-up over 34-38 years. J. Affective Disorders 2002; 68: 167-181.
5. Valtonen H et al. Suicidal ideation and attempts in bipolar 1 and II disorders. J Clin Psychiatry 2005; 66: 1456-1462.
6. Suppes T, Leverich GS, Keck PE, et al. The Stanley Foundation Bipolar Treatment Outcome Network II. Demographics and illness characteristics of the first 261 patients. J Affect Disord. 2001;67:45-59. why is this in blue?
7. Judd LL, Akiskal HS, Schettler PJ et al. The long-term natural history of the weekly symptomatic status of bipolar 1 disorder. Arch Gen Psychiatry 2002; 59: 530-7.
8. Michalak EE et al. The impact of bipolar disorder upon work functioning: a qualitative analysis. Bipolar Disord 2007; 9: 126-143.
9. Kessler RC. Prevalence and effects of mood disorders on work performance in a nationally representative sample of US workers. Am J Psychiat 2006; 163: 1561-82006
10. Martinez-Aran A et al. Cognitive function across manic or hypomanic, depressed and euthymic states in bipolar disorder. Am J Psychiat 2004; 161:262-270.
11. Kupfer DJ, Frank E, Grochocinski VJ, Cluss PA, Houck PR, Stapf DA. Demographic and clinical characteristics of individuals in a bipolar disorder case registry. J Clin Psychiatry. 2002;63:120-125. why is this in blue?
12. Goodwin, G.M, Vieta, E. Effective maintenance treatment - breaking the
cycle of bipolar disorder. European Psychiatry 2005; 20, 365-371.
13. Zarate CA. Antipsychotic drug side-effect issues in bipolar manic patients. J Clin Psychiatry 2000; 61 (Suppl 8): 52-61.
14. Young A, Newham JI. Lithium in mainenance therapy for bipolar disorder. J Psychopharmacol 2006; 20(suppl 2): 17-22.
15. Tohen M, Jacobs TG, Grundy SC et al. Efficacy of olanzepine in acute bipolar mania: a double-blind rndomised placebo-controlled study. Arch Gen Psychiatry 2000; 57: 841-9.
16. Young A. Bipolar Disorder - the Four Dimensions of Care. 7th International Review of Bipolar Disorders. Abstract book p.23
17. Clarkin JF, Carpenter D, Hull J et al. Effects of treatment and psycho-educational interventions for married patients with bipolar disorder and their spouses. Psychiatry Research 1998; 49: 531-33.
18. Colom F, Vieta E, Martinez-Aran A. A randomised trial on the efficacy of group psycho-education in the prophylaxis of recurrences in bipolar patients whose disease is in remission. Arch Gen Psychiatry 2003; 60: 402-7.
19. Perry A, Tarrier N, Morriss T et al. Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtaining treatment. BMJ 1999; 318: 149-153.
Written by:
By Olwen Glynn Owen
Olwen at macline
Official estimates say bipolar illness affects 1 to 4 per cent of the population but some researchers believe the real figure is closer to 10 per cent (1). The World Health Organization says it is already the sixth leading cause of disability (2).
There are two main types of bipolar disorder. People who have bipolar I will have experienced at least one severe episode of heightened mood or mania lasting a week, or a mix of manic and depressed symptoms. People with bipolar II will have experienced at least one major depression and some degree of mania although this may be much less severe than in bipolar I and is described as hypomania (3).
In severe cases of bipolar I mania, symptoms can take the form of delusions and hallucinations so must be treated promptly, usually in hospital. More usually, symptoms of mania and hypomania are less obvious; feelings of euphoria, grandiosity, impulsivity, recklessness, and a diminished need for sleep can be ascribed to youthful exuberance. At the depressive end of the spectrum, feelings of anxiety, irritability, hostility and depression can lead to violent or suicidal behaviour. Around one third of uncontrolled bipolar sufferers currently attempt suicide and about half of those succeed (4, 5).
Bipolar disorder typically makes itself felt in a person's late teens or early twenties. Men are just as likely to be affected as women. In nine out of ten cases it recurs periodically throughout life with an average of nine severe episodes over a course of about 20 years (6, 7). The ratio of depressive to manic episodes is greater than two to one in western populations. Compared with mania, episodes of depression also last much longer and carry a higher risk of suicide. Between episodes, sufferers can experience periods of relative calm and stability, with only normal mood variation, or minor symptoms. Today's treatments are geared to maintaining that state and, if or when symptoms erupt, to halting that process.
Diagnosis is difficult
The illness is complex and variable making it difficult for doctors to diagnose. All too often behaviours are marked down to a quirky personality or troubled adolescence. But bipolar disorder has nothing to do with personality, stresses Professor Allan Young, a prominent researcher in the field from University of British Columbia, Vancouver, Canada. "Early diagnosis and treatment are important because the condition impacts on so many aspects of a person's life," he emphasises.
"Unfortunately, bipolar disorder sufferers are more susceptible to anxiety which can adversely impact physical health and wellbeing," Professor Young adds. "There's also a strong risk of them abusing alcohol or other substances."
Misdiagnosis can be a problem as well as no diagnosis. "If bipolar sufferers are misdiagnosed as having only depression or anxiety and are treated with antidepressant drugs alone, there's a high risk of deteriorating", explains Professor Young. Similarly, treatment directed primarily at controlling and preventing mania, or efforts focussed on stopping substance abuse, can fail to tackle depressive symptoms.
Bipolar disorder sufferers are often highly intelligent and creative individuals. History reveals several, such as Charles Dickens and Beethoven, who used their bursts of manic energy to accomplish great achievements. But inability to keep the disorder in check can make it difficult for lesser mortals to hold down jobs and perform consistently well at work (8). Recent US research estimates that bipolar disorder costs the country over $14 billion dollars per year in lost productivity (9).
Bipolar disorder takes a heavy toll on the mind's ability to think, remember and reason normally, Professor Young points out (10). Not just through racing thoughts, lack of sleep, inattentiveness and impaired concentration, but also in more subtle, ways, collectively described as loss of 'executive functioning'. "This includes the ability to plan, dealing with emotions, organise, focus attention where needed, process information and access working memory" he explained. "It's the sort of thing we all take for granted but losing it can be terribly disabling for a bipolar patient."
It can also lead to breakdown of relationships. Bipolar patients are twice as likely to divorce compared to the general population (114). Bipolar mood swings also have repercussions on social life if resulting behaviours upset colleagues and friends as well as partners. Even close family members can sometimes find bipolar behaviours impossible to tolerate. That's probably the most compelling reason for getting bipolar disorder under control. Morbidity and mortality rates are higher in patients with bipolar disorder than they are for those patients suffering from cancer or cardiovascular disease.
Treatment has advanced
When sufferers do get diagnosed and treated - a process that can take up to 10 years - the type of treatment prescribed can vary and some may cause troublesome side effects.
Some older treatments cause so many problems that patients stop taking medication altogether, says psychiatrist Dr Heinz Grunze of Ludwig-Maximilians-University, Munich, Germany. Many patients have been expected to take up to four types of drugs daily, including several with unpleasant side effects (12, 13).
The former mainstay of bipolar treatment was the mood-stabilising therapy lithium. This is highly effective at controlling mania and is used as a maintenance therapy between episodes, as is the anticonvulsant valproate, but these drugs are now considered much less effective in preventing and controlling depressive symptoms and are less widely used (14). Patients receiving lithium need their blood monitoring and can experience side effects such as problems with thinking and memory, weight gain, and tremor that lead many to abandon treatment.
Psychiatrists believe treatment has advanced considerably over the past decade. Several effective new drugs for rapidly controlling mania are now available that can be used instead of, or to allow a reduction of, lithium, Professor Young explains: "Newer antipsychotic drugs, can control mania quickly without so many of the unwelcome side effects associated with older drugs (,15). In particular, it is the uncontrolled jerking or writhing movements that older drugs can cause that are so distressing and stigmatising."
Need for " whole person" treatment
"Doctors are now realising we need to look at patients in a wider sense than before," suggests Professor Young. Traditionally, doctors focussed on mania and depression and only judged drugs on how well they reduced these symptoms. Now they are realising how severely bipolar illness impacts on many aspects of life and acknowledge a need to assess drugs from other perspectives too (16). Side effects, including effects on weight and intellectual function, quality of life, ability to mix well with other people and whether or not a drug produces any consistent troubling minor symptoms are also important. "It is these kind of assessments that can better highlight when treatment is falling short of providing a remedy for the patient as a whole," he comments. Only when every domain of bipolar illness is addressed and doctors get the treatment right will patients get the best chance of fully recovering their ability to participate in normal life.
"What gets you well, keeps you well"
In the past, treatment of acute episodes of mania or depression were followed by a different mood-stabiliser therapy, notes Dr Grunze. The view now is that the treatment that gets you over the worst symptoms will also prevent them recurring. "What gets you well, keeps you well."
The fewer drugs a patient needs to take, the greater is the likelihood they will stick to treatment and take medication as directed. If one medicine is not sufficient, there may be alternatives to adding more drugs to treatment, argue patient groups. Talking therapies are also key, they believe, as is "psycho-education" (17, 18, 19). This is the process of learning to understand the nature of bipolar disorder and the importance of seeking help early when symptoms arise or get worse. It explains when and why medicines must be taken regularly, and teaches ways to cope. By avoiding destabilising triggers such as stress, overwork, and too little sleep, patients can help prevent acute episodes of mania and depression.
The new approach is to manage bipolar illness across all four dimensions - its impact on body, mind, emotions and social life. This means using both the effective medications and the non-drug interventions described above. If adopted by the majority of psychiatrists there is cause for optimism. New research, new thinking and new medicines should help revolutionise the prospects for bipolar patients restoring their life chances.
Mania signs
-- irritability
-- sleeping less without tiring
-- experiencing a rush of energy
-- uncontrolled spending
-- feeling more self-confident than usual
-- socialising/partying out of character
-- talking fast and more than usual
-- disjointed racing thoughts and ideas
-- difficulty concentrating
-- increased desire for sex
-- uncharacteristic reckless behaviour
Depression symptoms
-- prolonged sadness/crying
-- change in appetite: eating more/less
-- sleeping more than usual
-- loss of pleasure in usual interests
-- social withdrawal
-- feelings of worthlessness
-- suicidal thoughts
-- irritability, anger, anxiety
-- negativity and indifference
-- loss of energy/tiredness
References
1. Hirschfeld RM, Calabrese JR, Weissman MM et al. Screening for bipolar disorder in the community. J Clin Psychiatry 2003;64:53-59
2. World Health Organisation. The Global Burden of Disease summary. Harvard University Press. Cambridge. Mass 1996.
3. American Psychiatric Association. Diagnostic and statistics manual of mental disorders (DSM-IV-TR) 4th ed. 3rd rev. Washington DC. American Psychiat. Assoc 2000.
4. Angst F, Stassen HH, Clayton PJ et al. Mortality of patients with mood disorders: follow-up over 34-38 years. J. Affective Disorders 2002; 68: 167-181.
5. Valtonen H et al. Suicidal ideation and attempts in bipolar 1 and II disorders. J Clin Psychiatry 2005; 66: 1456-1462.
6. Suppes T, Leverich GS, Keck PE, et al. The Stanley Foundation Bipolar Treatment Outcome Network II. Demographics and illness characteristics of the first 261 patients. J Affect Disord. 2001;67:45-59. why is this in blue?
7. Judd LL, Akiskal HS, Schettler PJ et al. The long-term natural history of the weekly symptomatic status of bipolar 1 disorder. Arch Gen Psychiatry 2002; 59: 530-7.
8. Michalak EE et al. The impact of bipolar disorder upon work functioning: a qualitative analysis. Bipolar Disord 2007; 9: 126-143.
9. Kessler RC. Prevalence and effects of mood disorders on work performance in a nationally representative sample of US workers. Am J Psychiat 2006; 163: 1561-82006
10. Martinez-Aran A et al. Cognitive function across manic or hypomanic, depressed and euthymic states in bipolar disorder. Am J Psychiat 2004; 161:262-270.
11. Kupfer DJ, Frank E, Grochocinski VJ, Cluss PA, Houck PR, Stapf DA. Demographic and clinical characteristics of individuals in a bipolar disorder case registry. J Clin Psychiatry. 2002;63:120-125. why is this in blue?
12. Goodwin, G.M, Vieta, E. Effective maintenance treatment - breaking the
cycle of bipolar disorder. European Psychiatry 2005; 20, 365-371.
13. Zarate CA. Antipsychotic drug side-effect issues in bipolar manic patients. J Clin Psychiatry 2000; 61 (Suppl 8): 52-61.
14. Young A, Newham JI. Lithium in mainenance therapy for bipolar disorder. J Psychopharmacol 2006; 20(suppl 2): 17-22.
15. Tohen M, Jacobs TG, Grundy SC et al. Efficacy of olanzepine in acute bipolar mania: a double-blind rndomised placebo-controlled study. Arch Gen Psychiatry 2000; 57: 841-9.
16. Young A. Bipolar Disorder - the Four Dimensions of Care. 7th International Review of Bipolar Disorders. Abstract book p.23
17. Clarkin JF, Carpenter D, Hull J et al. Effects of treatment and psycho-educational interventions for married patients with bipolar disorder and their spouses. Psychiatry Research 1998; 49: 531-33.
18. Colom F, Vieta E, Martinez-Aran A. A randomised trial on the efficacy of group psycho-education in the prophylaxis of recurrences in bipolar patients whose disease is in remission. Arch Gen Psychiatry 2003; 60: 402-7.
19. Perry A, Tarrier N, Morriss T et al. Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtaining treatment. BMJ 1999; 318: 149-153.
Written by:
By Olwen Glynn Owen
Olwen at macline
суббота, 7 мая 2011 г.
Functional Impairment Across Bipolar Mood States
There is a lot of data on symptoms and the clinical outcome of bipolar disorder, but very limited data on what really matters to the patients and their relatives: functioning. An understanding of which domains of psychosocial functioning are mostly impaired in bipolar patients would be of clinical utility; as such information could contribute to the development of interventions focused upon functional restoration.
The objective was to assess specific life domains of functioning as well as the overall functioning in patients with bipolar disorder across different mood states (mania, depression, and remission). The sample was recruited via the Bipolar Disorders Program of the Hospital Clinic at the University of Barcelona (Spain), an internationally recognized center of excellence in bipolar disorder research.
The results showed that patients in acute episode experienced significantly poorer functioning compared to the euthymic and control groups across all domains. Particularly, participants in the depressive group showed more impairment than those in the (hypo) manic group in specific areas such as: autonomy, cognitive functioning, interpersonal relationships and leisure time as well as poorer overall functioning.
A number of studies have shown that a substantial proportion of bipolar patients experiencing unfavorable functioning extends to essentially all the areas of functioning. The severity of mood symptomatology has been associated with functional impairment in this population.
As Dr. Vieta says, "The results suggest those patients with depressive and manic episodes experience poor psychosocial functioning in distinct areas, and that those deficits persist in an attenuated form during periods of remission. These findings highlight the importance of treating both the symptoms of mania and depression aggressively, and also suggest that when patients are euthymic (in clinical remission), treatment should focus on rehabilitation measures to improve functioning".
This will be discussed in a future issue of Value in Health, the official journal of the International Society for Pharmacoeconomics and outcomes Research.
Source:
ISPOR
The objective was to assess specific life domains of functioning as well as the overall functioning in patients with bipolar disorder across different mood states (mania, depression, and remission). The sample was recruited via the Bipolar Disorders Program of the Hospital Clinic at the University of Barcelona (Spain), an internationally recognized center of excellence in bipolar disorder research.
The results showed that patients in acute episode experienced significantly poorer functioning compared to the euthymic and control groups across all domains. Particularly, participants in the depressive group showed more impairment than those in the (hypo) manic group in specific areas such as: autonomy, cognitive functioning, interpersonal relationships and leisure time as well as poorer overall functioning.
A number of studies have shown that a substantial proportion of bipolar patients experiencing unfavorable functioning extends to essentially all the areas of functioning. The severity of mood symptomatology has been associated with functional impairment in this population.
As Dr. Vieta says, "The results suggest those patients with depressive and manic episodes experience poor psychosocial functioning in distinct areas, and that those deficits persist in an attenuated form during periods of remission. These findings highlight the importance of treating both the symptoms of mania and depression aggressively, and also suggest that when patients are euthymic (in clinical remission), treatment should focus on rehabilitation measures to improve functioning".
This will be discussed in a future issue of Value in Health, the official journal of the International Society for Pharmacoeconomics and outcomes Research.
Source:
ISPOR
пятница, 6 мая 2011 г.
New book on bipolar disorder targets 12 million affected Americans, families
Nearly 4 percent of adults in the United States - almost 12 million people - suffer from some version of bipolar disorder. Commonly referred to as manic-depressive illness, bipolar disorder is characterized by cycles of mania, depression or mixed emotional states that often disrupt work, school, family and social life. Recent revelations by popular television host Jane Pauley and former Chicago Bear football star Alonzo Spellman on their struggles with bipolar disorder have shed light on what was once a very hidden and misunderstood disease. A new book, Bipolar Disorder For Dummies (Wiley, 340 pages, $19.99) breaks down the barriers to understanding, treating and living with this complex disease.
Bipolar Disorder For Dummies is a reassuring guide that explains the brain chemistry behind the disease, as well as the latest medications and therapies. It offers sound advice and self-help techniques that you and your loved ones can use to ease and eliminate symptoms, function in times of crisis, plan ahead for manic or depressive episodes, and feel better. Topics covered include: diagnosis and treatment, selecting a mental health specialist, mood charting, managing employment-related issues, how bipolar disorder affects children, and much more.
Written by Candida Fink, MD, a psychiatrist specializing in bipolar disorder, and Joe Kraynak, MA, a professional writer with a close family member diagnosed with bipolar disorder, Bipolar Disorder For Dummies delivers the latest information to help sufferers and loved ones learn about and cope with the disorder.
From diagnosis to planning ahead for relapses, Bipolar Disorder For Dummies provides readers with the tools and information they need to live with the disease. The book is divided into six parts, starting with an overview of bipolar disorder, and going onto: controlling the disease, treatment options, helping yourself, assisting a friend or relative and closing with a section called "The Part of Tens," a group of tips and questions you should ask to learn more about the disorder.
Dr. Fink specializes in child and adolescent psychiatry and has included a special chapter titled "Backing Your Bipolar Child," with ways family members can support a child with bipolar disorder. Below is a checklist from Dr. Fink to determine if your child is depressed or manic.
Is Your Child Depressed or Manic?
Bipolar disorder usually has a different look and feel in children than it has in adults, and it shares many symptoms with other problems, including anxiety, depression, and ADHD. Remain vigilant for the following warning signs:
- You see big changes in behavior; your child is doing much more or less than usual.
- Your child sleeps all the time or has plenty of energy with little or no sleep.
- He or she has a persistent irritable, angry mood over and above typical teenage behavior.
- Your child experiences uncontrollable rages or tantrums over minor day-to-day demands.
- He or she destroys property, shows aggression, or threatens to hurt others. (If you check this warning sign, seek help immediately.)
- Your child hates himself or feels as though he can do no wrong.
- He or she has withdrawn socially or has begun engaging in potentially dangerous activities, such as sex, drugs, excessive shopping, stealing, and so on.
- Your child persistently feels sadness, hopelessness, despair, or crushing boredom.
- You notice changes in your child's concentration, grades dropping, or problems in school.
- Your child has expressed suicidal thoughts or engaged in self-harm, such as cutting. (If you check this warning sign, call a professional immediately.)
Like all For Dummies® books, Bipolar Disorder For Dummies concludes with "The Part of Tens," including "Ten Questions to Ask a Psychiatrist or Therapist," "Ten Ways to Fight the High Cost of Treatment," and "Ten Ways to Help the Bipolar Community." A helpful "cheat sheet" gives symptoms to identify if you have ever been depressed, or manic/hypomanic, as well as ways to beat the blues and tips to muffle the mania.
Bipolar Disorder For Dummies provides sound advice and self-help techniques that you and your loved ones can use to ease and eliminate symptoms, function in times of crisis, plan ahead for manic or depressive episodes and feel better.
Denise Graveline
dgraveline1earthlink
Don't Get Caught
dontgetcaught.biz
Bipolar Disorder For Dummies is a reassuring guide that explains the brain chemistry behind the disease, as well as the latest medications and therapies. It offers sound advice and self-help techniques that you and your loved ones can use to ease and eliminate symptoms, function in times of crisis, plan ahead for manic or depressive episodes, and feel better. Topics covered include: diagnosis and treatment, selecting a mental health specialist, mood charting, managing employment-related issues, how bipolar disorder affects children, and much more.
Written by Candida Fink, MD, a psychiatrist specializing in bipolar disorder, and Joe Kraynak, MA, a professional writer with a close family member diagnosed with bipolar disorder, Bipolar Disorder For Dummies delivers the latest information to help sufferers and loved ones learn about and cope with the disorder.
From diagnosis to planning ahead for relapses, Bipolar Disorder For Dummies provides readers with the tools and information they need to live with the disease. The book is divided into six parts, starting with an overview of bipolar disorder, and going onto: controlling the disease, treatment options, helping yourself, assisting a friend or relative and closing with a section called "The Part of Tens," a group of tips and questions you should ask to learn more about the disorder.
Dr. Fink specializes in child and adolescent psychiatry and has included a special chapter titled "Backing Your Bipolar Child," with ways family members can support a child with bipolar disorder. Below is a checklist from Dr. Fink to determine if your child is depressed or manic.
Is Your Child Depressed or Manic?
Bipolar disorder usually has a different look and feel in children than it has in adults, and it shares many symptoms with other problems, including anxiety, depression, and ADHD. Remain vigilant for the following warning signs:
- You see big changes in behavior; your child is doing much more or less than usual.
- Your child sleeps all the time or has plenty of energy with little or no sleep.
- He or she has a persistent irritable, angry mood over and above typical teenage behavior.
- Your child experiences uncontrollable rages or tantrums over minor day-to-day demands.
- He or she destroys property, shows aggression, or threatens to hurt others. (If you check this warning sign, seek help immediately.)
- Your child hates himself or feels as though he can do no wrong.
- He or she has withdrawn socially or has begun engaging in potentially dangerous activities, such as sex, drugs, excessive shopping, stealing, and so on.
- Your child persistently feels sadness, hopelessness, despair, or crushing boredom.
- You notice changes in your child's concentration, grades dropping, or problems in school.
- Your child has expressed suicidal thoughts or engaged in self-harm, such as cutting. (If you check this warning sign, call a professional immediately.)
Like all For Dummies® books, Bipolar Disorder For Dummies concludes with "The Part of Tens," including "Ten Questions to Ask a Psychiatrist or Therapist," "Ten Ways to Fight the High Cost of Treatment," and "Ten Ways to Help the Bipolar Community." A helpful "cheat sheet" gives symptoms to identify if you have ever been depressed, or manic/hypomanic, as well as ways to beat the blues and tips to muffle the mania.
Bipolar Disorder For Dummies provides sound advice and self-help techniques that you and your loved ones can use to ease and eliminate symptoms, function in times of crisis, plan ahead for manic or depressive episodes and feel better.
Denise Graveline
dgraveline1earthlink
Don't Get Caught
dontgetcaught.biz
четверг, 5 мая 2011 г.
Organon's Asenapine Further Demonstrates Efficacy In Reducing Mania Symptoms For The Treatment Of Bipolar I Disorder
New data show that asenapine - a
psychopharmacologic agent being developed by Organon - is effective in
treating acute manic episodes associated with bipolar I disorder. These results,
from two Phase III clinical studies, were presented this week at the 20th
European College of Neuropsychopharmacology (ECNP) Congress.
"The results of these clinical trials add to the body of evidence supporting the clinical
efficacy and safety of asenapine," said Roger S. McIntyre, M.D., Associate Professor
of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood
Disorders Psychopharmacology Unit at the University Health Network, Toronto,
Canada. "The complex nature of bipolar disorders suggests that we should have many
treatment options available to physicians and patients. As such, a new therapy that
provides efficacy while also providing improved tolerability is critical in helping fill this
unmet need."
In a separate safety study, also presented at the ECNP, asenapine demonstrated
minimal effect on the QT interval (QTc) - a measure of the heart's electrical
conductance - in patients with schizophrenia.
Study overview: bipolar I disorder (presented on Tuesday, 16 October at 12:00
p.m. CEST)
In the two Phase III, randomized, double-blind trials (Ares 7501004 and Ares
7501005), 960 adult patients with moderate-to-severe mania associated with bipolar I
disorder received either asenapine (5-10 mg twice daily), olanzapine (5-20 mg once
daily), or placebo for three weeks.
At day 21 in both studies, both asenapine and olanzapine produced significant mean
improvements in mania symptoms versus placebo as measured by changes in YMRS
(Young Mania Rating Scale) score. The YMRS is an 11-item scale used to evaluate
manic symptoms. A difference in YMRS score reduction between the active treatments
and placebo was seen as early as day two1.
The overall incidences of treatment-related adverse events (AEs) for the two studies
were 55.1% and 60.8% in the asenapine groups, 46.8% and 52.9% in the olanzapine
groups, and 27.6% and 36.2% in the placebo groups. Most adverse events were mild
to moderate. The most commonly reported AEs (reported by >5% of the patients and
 
at twice the incidence of placebo in both studies) with asenapine included sedation,
dizziness and somnolence. Olanzapine was most commonly associated with sedation,
dizziness, somnolence and weight increase. The incidence of extrapyramidal
symptoms reported as an adverse event was 10.3% and 7.2% in the asenapine group,
6.8% and 7.9% in the olanzapine group, and 3.1% and 2.9% in the placebo group.
Asenapine-treated patients had approximately a two-fold lower incidence of clinically
significant weight gain (=7%) versus olanzapine-treated patients in Ares 7501004 (7%
vs. 19%, respectively) and in Ares 7501005 (6% vs.13%, respectively).
The study abstract, "Treatment of mania in bipolar I disorder: a placebo and
olanzapine-controlled trial of asenapine," (P.2.e.012) was presented at ECNP on
Tuesday, 16 October by Professor McIntyre.
Study overview: schizophrenia (presented on Sunday, 14 October at 12:00 p.m.
CEST)
This 16-day, multicenter study examined the effects of asenapine on the QT interval -
a measure of the heart's electrical conductance. A QTc >500 milliseconds (msec) and
an increase from baseline of >60 msec are risk factors for a potentially life-threatening
form of ventricular tachycardia called torsades de pointes.
In the study, 151 patients with schizophrenia or schizoaffective disorder were
randomized to asenapine (up to 20 mg twice daily), quetiapine 375 mg twice daily, or
placebo. Investigators measured QTc using electrocardiograms (ECGs), which were
administered several times throughout the 16-day study after asenapine
administration.
Asenapine at doses up to 20 mg twice daily had a minimal, not considered to be
clinically relevant, effect on QTc. Asenapine had an effect equal to or less than
quetiapine on QTc in this study.
The study abstract, "Effect of asenapine versus quetiapine and placebo on QTc
interval in patients with schizophrenia," (P.3.c.050) was presented at ECNP on
Sunday, 14 October by Sheldon H. Preskorn, M.D., Department of Psychiatry,
University of Kansas School of Medicine in Wichita.
About bipolar disorder
Bipolar disorder, commonly referred to as manic-depressive disorder, is a chronic,
episodic illness characterized by mania (episodes of elevated moods, extreme irritability,
and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts),
or a combination of both. It affects approximately one to five percent of adults, including
more than 10 million adults in the United States and more than four million people in
Europe2,3. The condition can start early in childhood or later in life, the average age of
onset is between 15 and 25 years old4. Bipolar disorder is the sixth leading cause of
disability in the world2. About half of the patients with bipolar disorder who recover in
response to treatment experience recurrence two years later5.
About schizophrenia
Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusions,
and disordered thinking. About 24 million people worldwide (or seven in every 1,000 adults in
the population) have schizophrenia6, including more than two million people in the U.S.7 and
more than four million people in Europe8. People with schizophrenia may hear voices other
people don't hear or may believe others are trying to harm them. As a result, they may become
socially withdrawn, fearful, and agitated7.
References
1. National Institute of Mental Health. Available online at:
nimh.nih/publicat/bipolar.cfm
2. Depression and Bipolar Support Alliance (DBSA). Bipolar Disorder Statistics, accessed on
May 10, 2007.
See here.
3. World Health Organization. WHO European Ministry Conference on Mental Health.
Available online at: euro.who.int/document/MNH/emnhqa.pdf. Accessed on
October 2, 2007
4. National Alliance on Mental Health. Understanding Bipolar Disorder and Recovery.
Available online
here.
5. Perlis RH, Ostacher MJ, Patel JK. Predictors of Recurrence in Bipolar Disorder: Primary
Outcomes from the Systemic Treatment Enhancement Program for Bipolar Disorder
(STEP-BD). Am J Psychiatry. 2006;163:210-224.
6. World Health Organization. Available online
here. Accessed on October
2, 2007.
7. National Institute of Mental Health. Available online
here.
8. World Health Organization. WHO European Ministry Conference on Mental Health.
Available online at: euro.who.int/document/MNH/emnhqa.pdf. Accessed on
October 2, 2007.
About Organon
Organon creates, manufactures and markets innovative prescription medicines that improve
the health and quality of human life. Through a combination of innovation and business
partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company
in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It
has extensive expertise in neuroscience and a rich and focused R&D program. Research areas
also include immunology and specific areas of oncology. Organon products are distributed in
over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is
the human healthcare business unit of Akzo Nobel.
Safe Harbor Statement*
This press release may contain statements which address such key issues as growth strategy, future financial
results, market positions, product development, pharmaceutical products in the pipeline, and product approvals
of Organon. Such statements should be carefully considered, and it should be understood that many factors
could cause forecasted and actual results to differ from these statements. These factors include, but are not
limited to, price fluctuations, currency fluctuations, progress of drug development, clinical testing and regulatory
approval, developments in raw material and personnel costs, pensions, physical and environmental risks, legal
issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on
management estimates supported by information provided by specialized external agencies. For a more
comprehensive discussion of the risk factors affecting our business please see our Annual Report on Form 20F filed with the United States Securities and Exchange Commission, a copy of which can be found on the
company's corporate website akzonobel.
* Pursuant to the U.S. Private Securities Litigation Reform Act 1995.
organon
psychopharmacologic agent being developed by Organon - is effective in
treating acute manic episodes associated with bipolar I disorder. These results,
from two Phase III clinical studies, were presented this week at the 20th
European College of Neuropsychopharmacology (ECNP) Congress.
"The results of these clinical trials add to the body of evidence supporting the clinical
efficacy and safety of asenapine," said Roger S. McIntyre, M.D., Associate Professor
of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood
Disorders Psychopharmacology Unit at the University Health Network, Toronto,
Canada. "The complex nature of bipolar disorders suggests that we should have many
treatment options available to physicians and patients. As such, a new therapy that
provides efficacy while also providing improved tolerability is critical in helping fill this
unmet need."
In a separate safety study, also presented at the ECNP, asenapine demonstrated
minimal effect on the QT interval (QTc) - a measure of the heart's electrical
conductance - in patients with schizophrenia.
Study overview: bipolar I disorder (presented on Tuesday, 16 October at 12:00
p.m. CEST)
In the two Phase III, randomized, double-blind trials (Ares 7501004 and Ares
7501005), 960 adult patients with moderate-to-severe mania associated with bipolar I
disorder received either asenapine (5-10 mg twice daily), olanzapine (5-20 mg once
daily), or placebo for three weeks.
At day 21 in both studies, both asenapine and olanzapine produced significant mean
improvements in mania symptoms versus placebo as measured by changes in YMRS
(Young Mania Rating Scale) score. The YMRS is an 11-item scale used to evaluate
manic symptoms. A difference in YMRS score reduction between the active treatments
and placebo was seen as early as day two1.
The overall incidences of treatment-related adverse events (AEs) for the two studies
were 55.1% and 60.8% in the asenapine groups, 46.8% and 52.9% in the olanzapine
groups, and 27.6% and 36.2% in the placebo groups. Most adverse events were mild
to moderate. The most commonly reported AEs (reported by >5% of the patients and
 
at twice the incidence of placebo in both studies) with asenapine included sedation,
dizziness and somnolence. Olanzapine was most commonly associated with sedation,
dizziness, somnolence and weight increase. The incidence of extrapyramidal
symptoms reported as an adverse event was 10.3% and 7.2% in the asenapine group,
6.8% and 7.9% in the olanzapine group, and 3.1% and 2.9% in the placebo group.
Asenapine-treated patients had approximately a two-fold lower incidence of clinically
significant weight gain (=7%) versus olanzapine-treated patients in Ares 7501004 (7%
vs. 19%, respectively) and in Ares 7501005 (6% vs.13%, respectively).
The study abstract, "Treatment of mania in bipolar I disorder: a placebo and
olanzapine-controlled trial of asenapine," (P.2.e.012) was presented at ECNP on
Tuesday, 16 October by Professor McIntyre.
Study overview: schizophrenia (presented on Sunday, 14 October at 12:00 p.m.
CEST)
This 16-day, multicenter study examined the effects of asenapine on the QT interval -
a measure of the heart's electrical conductance. A QTc >500 milliseconds (msec) and
an increase from baseline of >60 msec are risk factors for a potentially life-threatening
form of ventricular tachycardia called torsades de pointes.
In the study, 151 patients with schizophrenia or schizoaffective disorder were
randomized to asenapine (up to 20 mg twice daily), quetiapine 375 mg twice daily, or
placebo. Investigators measured QTc using electrocardiograms (ECGs), which were
administered several times throughout the 16-day study after asenapine
administration.
Asenapine at doses up to 20 mg twice daily had a minimal, not considered to be
clinically relevant, effect on QTc. Asenapine had an effect equal to or less than
quetiapine on QTc in this study.
The study abstract, "Effect of asenapine versus quetiapine and placebo on QTc
interval in patients with schizophrenia," (P.3.c.050) was presented at ECNP on
Sunday, 14 October by Sheldon H. Preskorn, M.D., Department of Psychiatry,
University of Kansas School of Medicine in Wichita.
About bipolar disorder
Bipolar disorder, commonly referred to as manic-depressive disorder, is a chronic,
episodic illness characterized by mania (episodes of elevated moods, extreme irritability,
and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts),
or a combination of both. It affects approximately one to five percent of adults, including
more than 10 million adults in the United States and more than four million people in
Europe2,3. The condition can start early in childhood or later in life, the average age of
onset is between 15 and 25 years old4. Bipolar disorder is the sixth leading cause of
disability in the world2. About half of the patients with bipolar disorder who recover in
response to treatment experience recurrence two years later5.
About schizophrenia
Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusions,
and disordered thinking. About 24 million people worldwide (or seven in every 1,000 adults in
the population) have schizophrenia6, including more than two million people in the U.S.7 and
more than four million people in Europe8. People with schizophrenia may hear voices other
people don't hear or may believe others are trying to harm them. As a result, they may become
socially withdrawn, fearful, and agitated7.
References
1. National Institute of Mental Health. Available online at:
nimh.nih/publicat/bipolar.cfm
2. Depression and Bipolar Support Alliance (DBSA). Bipolar Disorder Statistics, accessed on
May 10, 2007.
See here.
3. World Health Organization. WHO European Ministry Conference on Mental Health.
Available online at: euro.who.int/document/MNH/emnhqa.pdf. Accessed on
October 2, 2007
4. National Alliance on Mental Health. Understanding Bipolar Disorder and Recovery.
Available online
here.
5. Perlis RH, Ostacher MJ, Patel JK. Predictors of Recurrence in Bipolar Disorder: Primary
Outcomes from the Systemic Treatment Enhancement Program for Bipolar Disorder
(STEP-BD). Am J Psychiatry. 2006;163:210-224.
6. World Health Organization. Available online
here. Accessed on October
2, 2007.
7. National Institute of Mental Health. Available online
here.
8. World Health Organization. WHO European Ministry Conference on Mental Health.
Available online at: euro.who.int/document/MNH/emnhqa.pdf. Accessed on
October 2, 2007.
About Organon
Organon creates, manufactures and markets innovative prescription medicines that improve
the health and quality of human life. Through a combination of innovation and business
partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company
in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It
has extensive expertise in neuroscience and a rich and focused R&D program. Research areas
also include immunology and specific areas of oncology. Organon products are distributed in
over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is
the human healthcare business unit of Akzo Nobel.
Safe Harbor Statement*
This press release may contain statements which address such key issues as growth strategy, future financial
results, market positions, product development, pharmaceutical products in the pipeline, and product approvals
of Organon. Such statements should be carefully considered, and it should be understood that many factors
could cause forecasted and actual results to differ from these statements. These factors include, but are not
limited to, price fluctuations, currency fluctuations, progress of drug development, clinical testing and regulatory
approval, developments in raw material and personnel costs, pensions, physical and environmental risks, legal
issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on
management estimates supported by information provided by specialized external agencies. For a more
comprehensive discussion of the risk factors affecting our business please see our Annual Report on Form 20F filed with the United States Securities and Exchange Commission, a copy of which can be found on the
company's corporate website akzonobel.
* Pursuant to the U.S. Private Securities Litigation Reform Act 1995.
organon
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