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
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