The European journal Psychotherapy and Psychosomatics launched a debate in 2003 on the relationship between selective serotonin reuptake inhibitors and new onset of suicidal ideations. Some American studies seemed to deny this phenomenon. But a new study performed in the US with international investigators would confirm that a relationship does exist.
Some reports suggest that a subset of depressed patients may experience suicidality - that is increase or emergence of suicidal ideation (SI) or behavior - after initiation of an antidepressant. The time course and clinical correlates of this phenomenon have not been characterized in detail. We conducted a secondary analysis of a multicenter, prospective, open, 12-week trial of fluoxetine 20 mg in outpatients with nonpsychotic major depressive episodes.
Adverse effects and other clinical features associated with the emergence of suicidality, defined using item 3 of the Hamilton Depression Rating Scale, were examined using Cox regression models. Among 414 subjects without SI at baseline, 59 (14.3%) reported SI on at least 1 postbaseline visit.
In a Cox regression, emergence of activation and worsening of depression severity were independently associated with emergence of SI, along with female gender, younger age and having thoughts that life was not worth living prior to treatment.
Treatment response and remission were significantly less likely among subjects who developed SI. New SI was relatively common in this trial of fluoxetine and associated with the emergence of activation and overall symptomatic worsening. Whether prophylaxis against or aggressive treatment of adverse events can decrease emergence of SI merits further study.
Treatment-Associated Suicidal Ideation and Adverse Effects in an Open, Multicenter Trial of Fluoxetine for Major Depressive Episodes
Perlis, R.H. ; Beasley, Jr., C.M. ; Wines, Jr., J.D. ; Tamura, R.N. ; Cusin, C. ; Shear, D. ; Amsterdam, J. ; Quitkin, F. ; Strong, R.E. ; Rosenbaum, J.F ; Fava, M.
Psychother Psychosom 2007;76:40-46
Click here to see abstract online
karger
суббота, 30 апреля 2011 г.
пятница, 29 апреля 2011 г.
Intensive Psychotherapy More Effective Than Brief Therapy For Treating Bipolar Depression
Patients taking medications to treat bipolar disorder are more likely to get well faster and stay well if they receive intensive psychotherapy, according to results from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), funded by the National Institutes of Health's (NIH) National Institute of Mental Health (NIMH). The results are published in the April 2007 issue of the Archives of General Psychiatry.
Bipolar disorder is a debilitating illness marked by severe mood swings between depression and mania that affects 2.6 percent of Americans in any given year. "We know that medication is an important component in the treatment of bipolar illness. These new results suggest that adding specific, targeted psychotherapy to medication may help give patients a better shot at lasting recovery," said NIH Director Dr. Elias A. Zerhouni.
"STEP-BD is helping us identify the best tools-both medications and psychosocial treatments-that patients and their clinicians can use to battle the symptoms of this illness," said NIMH Director Thomas R. Insel, M.D.
Psychotherapy is routinely employed as a means to treat bipolar illness in conjunction with medication, but the extent to which psychotherapy is effective has been unclear. In addition, most psychotherapeutic studies have been limited to a single site and compared only one type of treatment to routine care. Thus, in addition to examining the role of medication, STEP-BD set out to compare several types of psychotherapy and pinpoint the most effective treatments and treatment combinations.
With 293 participants, David Miklowitz, Ph.D., of the University of Colorado and colleagues set out to test the effectiveness of three types of standardized, intensive, nine-month-long psychotherapy compared to a control group that received a three-session, psychoeducational program called collaborative care. The intensive therapies were:
* family-focused therapy, which required the participation and input of patients' family members and focused on enhancing family coping, communication and problem-solving;
* cognitive behavioral therapy, which focused on helping the patient understand distortions in thinking and activity, and learn new ways of coping with the illness; and
* interpersonal and social rhythm therapy, which focused on helping the patient stabilize his or her daily routines and sleep/wake cycles, and solve key relationship problems.
All participants were already taking medication for their bipolar disorder, and most were also enrolled in a STEP-BD medication study reported in the New England Journal of Medicine online on March 28, 2007. The researchers compared patients' time to recovery and their stability over one year.
Over the course of the year, 64 percent of those in the intensive psychotherapy groups had become well, compared with 52 percent of those in collaborative care therapy. Patients in intensive psychotherapy also became well an average of 110 days faster than those in collaborative care. In addition, patients who received intensive psychotherapy were one and a half times more likely to be clinically well during any month out of the study year than those who received collaborative care. Discontinuation rates among the groups were similar-36 percent of those in the intensive programs discontinued and 31 percent of those in collaborative care discontinued. None of the three intensive psychotherapies appeared to be significantly more effective than the others, although rates of recovery were higher among those in family-focused therapy compared to the other groups.
"Intensive psychotherapy, when used as an adjunctive treatment to medication, can significantly enhance a person's chances for recovering from depression and staying healthy over the long term," said Dr. Miklowitz. "It should be considered a vital part of the effort to treat bipolar illness."
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/.
Miklowitz D. et al. Psychosocial Treatments for Bipolar Depression. Archives of General Psychiatry. Apr 2007; 164.
Contact: Colleen Labbe
NIH/National Institute of Mental Health
Bipolar disorder is a debilitating illness marked by severe mood swings between depression and mania that affects 2.6 percent of Americans in any given year. "We know that medication is an important component in the treatment of bipolar illness. These new results suggest that adding specific, targeted psychotherapy to medication may help give patients a better shot at lasting recovery," said NIH Director Dr. Elias A. Zerhouni.
"STEP-BD is helping us identify the best tools-both medications and psychosocial treatments-that patients and their clinicians can use to battle the symptoms of this illness," said NIMH Director Thomas R. Insel, M.D.
Psychotherapy is routinely employed as a means to treat bipolar illness in conjunction with medication, but the extent to which psychotherapy is effective has been unclear. In addition, most psychotherapeutic studies have been limited to a single site and compared only one type of treatment to routine care. Thus, in addition to examining the role of medication, STEP-BD set out to compare several types of psychotherapy and pinpoint the most effective treatments and treatment combinations.
With 293 participants, David Miklowitz, Ph.D., of the University of Colorado and colleagues set out to test the effectiveness of three types of standardized, intensive, nine-month-long psychotherapy compared to a control group that received a three-session, psychoeducational program called collaborative care. The intensive therapies were:
* family-focused therapy, which required the participation and input of patients' family members and focused on enhancing family coping, communication and problem-solving;
* cognitive behavioral therapy, which focused on helping the patient understand distortions in thinking and activity, and learn new ways of coping with the illness; and
* interpersonal and social rhythm therapy, which focused on helping the patient stabilize his or her daily routines and sleep/wake cycles, and solve key relationship problems.
All participants were already taking medication for their bipolar disorder, and most were also enrolled in a STEP-BD medication study reported in the New England Journal of Medicine online on March 28, 2007. The researchers compared patients' time to recovery and their stability over one year.
Over the course of the year, 64 percent of those in the intensive psychotherapy groups had become well, compared with 52 percent of those in collaborative care therapy. Patients in intensive psychotherapy also became well an average of 110 days faster than those in collaborative care. In addition, patients who received intensive psychotherapy were one and a half times more likely to be clinically well during any month out of the study year than those who received collaborative care. Discontinuation rates among the groups were similar-36 percent of those in the intensive programs discontinued and 31 percent of those in collaborative care discontinued. None of the three intensive psychotherapies appeared to be significantly more effective than the others, although rates of recovery were higher among those in family-focused therapy compared to the other groups.
"Intensive psychotherapy, when used as an adjunctive treatment to medication, can significantly enhance a person's chances for recovering from depression and staying healthy over the long term," said Dr. Miklowitz. "It should be considered a vital part of the effort to treat bipolar illness."
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/.
Miklowitz D. et al. Psychosocial Treatments for Bipolar Depression. Archives of General Psychiatry. Apr 2007; 164.
Contact: Colleen Labbe
NIH/National Institute of Mental Health
четверг, 28 апреля 2011 г.
APA Applauds Congressional Efforts To Promote Research And Education On Mental Illnesses, USA
Arlington, Va. -The American Psychiatric Association (APA) applauds the efforts of U.S. Representative Sue Myrick (R-N.C.) who initiated an Energy and Commerce Subcommittee on Health hearing held today on mental health disorders, entitled "Mental Illness and Brain Disease: Dispelling Myths and Promoting Recovery Through Awareness and Treatment." At the hearing, overseen by Subcommittee Chairman Representative Nathan Deal (R-Ga.), experts testified about important advances in research that have improved the treatment options for mental disorders like depression, bipolar disorder, and schizophrenia.
Over the past five years, the nation has more than doubled its investment in the study of the human brain and behavior, leading to a vastly expanded understanding of postpartum depression, bipolar disorder and attention-deficit/hyperactivity disorder, to name a few. With the aid of this research and consumer education, physicians can accurately diagnose and effectively treat patients with mental health concerns.
"The need for research on mental disorders is vital for our troops [returning from combat] and to all American citizens," testified Raymond DePaulo, Jr., M.D., Henry Phipps Professor and Chairman of the Department of Psychiatry at The Johns Hopkins University School of Medicine, and a member of the APA Committee on Psychiatric Diagnosis and Assessment. "About 15 million people in the United States at any given time have major depression or some form of manic depression. The prevalence for depression runs very high, as do the costs to the individual and the country as a whole. It is imperative that we invest more time and money towards this 'Cancer of the 21st Century,' so that treatments can lead to cures and hopes into reality."
The APA encourages everyone to learn more about the facts on mental illnesses. For more information, visit the APA's "Healthy Minds. Healthy Lives." Web site HealthyMinds for free public education materials.
About the American Psychiatric Association:
The American Psychiatric Association is the nation's leading 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.
Over the past five years, the nation has more than doubled its investment in the study of the human brain and behavior, leading to a vastly expanded understanding of postpartum depression, bipolar disorder and attention-deficit/hyperactivity disorder, to name a few. With the aid of this research and consumer education, physicians can accurately diagnose and effectively treat patients with mental health concerns.
"The need for research on mental disorders is vital for our troops [returning from combat] and to all American citizens," testified Raymond DePaulo, Jr., M.D., Henry Phipps Professor and Chairman of the Department of Psychiatry at The Johns Hopkins University School of Medicine, and a member of the APA Committee on Psychiatric Diagnosis and Assessment. "About 15 million people in the United States at any given time have major depression or some form of manic depression. The prevalence for depression runs very high, as do the costs to the individual and the country as a whole. It is imperative that we invest more time and money towards this 'Cancer of the 21st Century,' so that treatments can lead to cures and hopes into reality."
The APA encourages everyone to learn more about the facts on mental illnesses. For more information, visit the APA's "Healthy Minds. Healthy Lives." Web site HealthyMinds for free public education materials.
About the American Psychiatric Association:
The American Psychiatric Association is the nation's leading 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.
среда, 27 апреля 2011 г.
New Report Finds Little Evidence To Determine The Usefulness Of Genetic Tests In The Treatment Of Depression
There is insufficient
evidence to determine if current gene-based tests intended to personalize
the dose of medications in a class of drugs called selective serotonin
reuptake inhibitors (SSRIs) improve patient outcomes or aid in treatment
decisions in the clinical setting, according to a new evidence report
supported by a collaboration of the Agency for Healthcare Research and
Quality (AHRQ) and the Centers for Disease Control and Prevention's (CDC)
National Office of Public Health Genomics.
This evidence report is the first step in the two-step process of CDC's
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) pilot
project to evaluate and make recommendations regarding the use of
gene-based tests. Funding for the report was provided by CDC.
The report found that tests evaluating differences in genes belonging
to the Cytochrome P450, or CYP450, family that affect the rate at which a
person metabolizes SSRIs are largely accurate. However, the researchers did
not find any evidence that such tests led to improved patient outcomes or
had an impact on treatment decisions for patients with depression. The
researchers noted that other genetic factors and non-genetic factors such
as diet and other medical conditions may have an impact on a patient's
response to treatment.
"This report highlights how systematically reviewing scientific
findings can help guide future research," said Beth A. Collins Sharp,
Ph.D., R.N., director of AHRQ's Evidence-based Practice Center Program.
"This information will help identify the types of studies that are
necessary to help better understand various treatment response issues."
Researchers performed a comprehensive review of the literature and
found no well-designed studies that evaluated clinical outcomes of tests to
detect differences in genes belonging to the CYP450 family. These genes
produce enzymes that break down SSRIs and many other classes of drugs. Most
studies included a small number of people, did not test for all variations
of the enzymes and were poorly designed, according to the researchers. The
majority of studies also reported the rate of metabolism after just one
dose or were done in patients without depression -- factors that do not
accurately represent the long-term use of these drugs in patients with
depression.
Because patient response to SSRIs varies, there has been strong
interest in using gene-based tests to predict whether the person will be a
poor, intermediate, extensive or ultra-rapid metabolizer. Theoretically,
ultra-rapid metabolizers could require higher doses than those who
metabolize the drug slowly. Poor metabolizers might respond to a lower
dose, which could also prevent side effects. The goal of testing is to
personalize health care by selecting therapy based on a patient's genetic
makeup.
The report found a relationship between genetic differences and the
occurrence of adverse effects from SSRIs in depressed patients in only two
of six studies. However, the researchers concluded that all six studies
were poorly designed, which limits the ability to draw conclusions about
how differences in CYP450 genes influence adverse effects of SSRIs.
"This report emphasizes that well-designed observational studies and
clinical trials are needed to clearly establish the clinical validity and
utility of the many emerging genomic tests for treatment and prevention of
common diseases of public health significance," said Muin Khoury, M.D.,
Ph.D., director of CDC's National Office of Public Health Genomics. "Early
availability of the evidence base is key to the effective use of genomics
for the benefit of population health."
Since their introduction in the late 1980s, SSRIs (such as citalopram,
fluoxetine, paroxetine and sertraline) have become the most commonly
prescribed class of drugs for treatment of depression. However, the
likelihood that a person will experience relief from all symptoms of
depression after one year of treatment is approximately 40 percent, and
side effects cause 12 percent to 15 percent of people who start treatment
to stop taking the drug. Following the recent FDA approval of a test to
predict differences in the CYP450 gene, clinicians and patients must decide
whether using such tests to choose a type or dose of an SSRI might improve
the patient's response to treatment.
In early 2007, the EGAPP working group, an independent, non-federal
panel that advises the CDC, will issue recommendations on the use of CYP450
tests in the treatment of depression based on the evidence report and other
considerations, including alternative approaches for dosing and monitoring
of drug therapy, patient access to testing and cost. The working group will
also assess current knowledge gaps and describe additional research needs
identified by the report. Future evidence reports that are part of the
AHRQ/CDC collaboration will evaluate the use of genomic tests for specific
diseases or conditions, such as a rare type of inherited colorectal cancer.
The report was prepared by a team of researchers led by David Matchar,
M.D., and Mugdha Thakur, M.D., of AHRQ's Duke University Evidence-based
Practice Center in Durham, N.C. "Testing for CYP450 Polymorphisms in Adults
With Non-Psychotic Depression Treated With SSRIs" can be found online at ahrq/clinic/tp/cyp450tp.htm.
Agency for Healthcare Research and Quality
ahrq/clinic/tp/cyp450tp.htm
evidence to determine if current gene-based tests intended to personalize
the dose of medications in a class of drugs called selective serotonin
reuptake inhibitors (SSRIs) improve patient outcomes or aid in treatment
decisions in the clinical setting, according to a new evidence report
supported by a collaboration of the Agency for Healthcare Research and
Quality (AHRQ) and the Centers for Disease Control and Prevention's (CDC)
National Office of Public Health Genomics.
This evidence report is the first step in the two-step process of CDC's
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) pilot
project to evaluate and make recommendations regarding the use of
gene-based tests. Funding for the report was provided by CDC.
The report found that tests evaluating differences in genes belonging
to the Cytochrome P450, or CYP450, family that affect the rate at which a
person metabolizes SSRIs are largely accurate. However, the researchers did
not find any evidence that such tests led to improved patient outcomes or
had an impact on treatment decisions for patients with depression. The
researchers noted that other genetic factors and non-genetic factors such
as diet and other medical conditions may have an impact on a patient's
response to treatment.
"This report highlights how systematically reviewing scientific
findings can help guide future research," said Beth A. Collins Sharp,
Ph.D., R.N., director of AHRQ's Evidence-based Practice Center Program.
"This information will help identify the types of studies that are
necessary to help better understand various treatment response issues."
Researchers performed a comprehensive review of the literature and
found no well-designed studies that evaluated clinical outcomes of tests to
detect differences in genes belonging to the CYP450 family. These genes
produce enzymes that break down SSRIs and many other classes of drugs. Most
studies included a small number of people, did not test for all variations
of the enzymes and were poorly designed, according to the researchers. The
majority of studies also reported the rate of metabolism after just one
dose or were done in patients without depression -- factors that do not
accurately represent the long-term use of these drugs in patients with
depression.
Because patient response to SSRIs varies, there has been strong
interest in using gene-based tests to predict whether the person will be a
poor, intermediate, extensive or ultra-rapid metabolizer. Theoretically,
ultra-rapid metabolizers could require higher doses than those who
metabolize the drug slowly. Poor metabolizers might respond to a lower
dose, which could also prevent side effects. The goal of testing is to
personalize health care by selecting therapy based on a patient's genetic
makeup.
The report found a relationship between genetic differences and the
occurrence of adverse effects from SSRIs in depressed patients in only two
of six studies. However, the researchers concluded that all six studies
were poorly designed, which limits the ability to draw conclusions about
how differences in CYP450 genes influence adverse effects of SSRIs.
"This report emphasizes that well-designed observational studies and
clinical trials are needed to clearly establish the clinical validity and
utility of the many emerging genomic tests for treatment and prevention of
common diseases of public health significance," said Muin Khoury, M.D.,
Ph.D., director of CDC's National Office of Public Health Genomics. "Early
availability of the evidence base is key to the effective use of genomics
for the benefit of population health."
Since their introduction in the late 1980s, SSRIs (such as citalopram,
fluoxetine, paroxetine and sertraline) have become the most commonly
prescribed class of drugs for treatment of depression. However, the
likelihood that a person will experience relief from all symptoms of
depression after one year of treatment is approximately 40 percent, and
side effects cause 12 percent to 15 percent of people who start treatment
to stop taking the drug. Following the recent FDA approval of a test to
predict differences in the CYP450 gene, clinicians and patients must decide
whether using such tests to choose a type or dose of an SSRI might improve
the patient's response to treatment.
In early 2007, the EGAPP working group, an independent, non-federal
panel that advises the CDC, will issue recommendations on the use of CYP450
tests in the treatment of depression based on the evidence report and other
considerations, including alternative approaches for dosing and monitoring
of drug therapy, patient access to testing and cost. The working group will
also assess current knowledge gaps and describe additional research needs
identified by the report. Future evidence reports that are part of the
AHRQ/CDC collaboration will evaluate the use of genomic tests for specific
diseases or conditions, such as a rare type of inherited colorectal cancer.
The report was prepared by a team of researchers led by David Matchar,
M.D., and Mugdha Thakur, M.D., of AHRQ's Duke University Evidence-based
Practice Center in Durham, N.C. "Testing for CYP450 Polymorphisms in Adults
With Non-Psychotic Depression Treated With SSRIs" can be found online at ahrq/clinic/tp/cyp450tp.htm.
Agency for Healthcare Research and Quality
ahrq/clinic/tp/cyp450tp.htm
вторник, 26 апреля 2011 г.
Lithium Therapy Improvement By Reduction Of Its Toxicity
Lithium is the most effective treatment for bipolar disorder. However, its use is limited because of neurological side effects and a risk for overdose-induced toxicity. Many of the beneficial effects of lithium are mediated by its inhibition of GSK-3 proteins, but whether this is the mechanism underlying its negative effects has not been determined.
However, Raquel GГіmez-Sintes and JosГ© Lucas, at CSIC/UAM, Spain, have now delineated a molecular pathway by which chronic administration of therapeutic doses of lithium has negative effects in mice.
Specifically, they found that gait abnormalities and nerve cell death in several regions of the brain were a result of GSK-3 protein inhibition, which led to increased nuclear localization of NFATc3/4 proteins and increased levels of the death-inducing molecule Fas ligand. The authors hope that these data might provide new ideas for combination therapies that diminish the toxicities of lithium, which has been proposed as a treatment for Alzheimer disease.
TITLE: NFAT/Fas signaling mediates the neuronal apoptosis and motor side effects of GSK-3 inhibition in a mouse model of lithium therapy
Source:
Karen Honey
Journal of Clinical Investigation
However, Raquel GГіmez-Sintes and JosГ© Lucas, at CSIC/UAM, Spain, have now delineated a molecular pathway by which chronic administration of therapeutic doses of lithium has negative effects in mice.
Specifically, they found that gait abnormalities and nerve cell death in several regions of the brain were a result of GSK-3 protein inhibition, which led to increased nuclear localization of NFATc3/4 proteins and increased levels of the death-inducing molecule Fas ligand. The authors hope that these data might provide new ideas for combination therapies that diminish the toxicities of lithium, which has been proposed as a treatment for Alzheimer disease.
TITLE: NFAT/Fas signaling mediates the neuronal apoptosis and motor side effects of GSK-3 inhibition in a mouse model of lithium therapy
Source:
Karen Honey
Journal of Clinical Investigation
понедельник, 25 апреля 2011 г.
CDC Finds Increase In Teen Suicide; NYU Child Study Center Responds -- Identifies Warning Signs And Provides Tips For Parents
The New York University
Child Study Center has identified warning signs of depression in teenagers
for parents and tips for helping teens who may be depressed, in light of a
new report from the Centers for Disease Control and Prevention (CDC). The
CDC study, published in the February 2007 issue of Pediatrics finds that
suicide rates in children under 19 years of age increased between 2003 and
2004. Suicide was the only statistically significant increase in child
death over this time. Overall, the suicide rate increased by 18.2 percent
from 2003 to 2004, an increase largely driven by older teens.
"A teen's statement of a wish to kill him/herself must be taken
seriously," said Lori Evans, Ph.D., Director of Psychology Training and the
Project Coordinator of TASA (Treatment of Adolescent Suicide Attempters) at
the NYU Child Study Center. "Before they actually commit or attempt
suicide, teens often make direct statements about their intention to end
their lives, or less direct statements about how they might as well be dead
or that their friends and family would be better off without them."
"Discussing the problem does not encourage the teenager to go through
with the plan," emphasizes Dr. Evans. "On the contrary, it will help him or
her know that someone is willing to be a friend. It may save your
adolescent's life."
Watch for symptoms of depression lasting longer than two weeks, which
may include:
-- A change in eating and sleeping habits
-- A marked personality change, exhibiting angry actions or rebellious
behavior or withdrawal from friends and regular activities
-- Involvement in drugs or alcohol or other risky behaviors such as
reckless driving
-- An overreaction to a recent humiliating experience
-- Difficulty in concentrating and a decline in the quality of school work
-- Persistent boredom and/or lethargy
-- Unusual neglect of appearance
-- Complaints about physical symptoms such as headaches and fatigue
-- A pattern of giving away or throwing away possessions
-- Intolerance of praise or rewards
-- Preoccupation with death in writing songs or poems
-- An increase in comments such as "I can't take it anymore" or "nobody
cares; I wish I was dead"
How to help
-- Take person's comments regarding self-hate, suicide, or death very
seriously
-- Don't try to convince the person to not feel bad. Don't tell them to
"snap out of it" or say "don't feel bad"
-- Keep in close contact with the person and their parent, teacher, or a
good friend
-- Ask the child or teen what you could do that would be helpful to them
-- Don't promise to keep any information a secret
-- If symptoms persist or are dangerous and interfere with daily
functioning, consult a mental health professional immediately
Dr. Lori Evans is the Coordinator of TASA (Treatment of Adolescent
Suicide Attempters) and the Director of Psychology Training at the NYU
Child Study Center. TASA is a multi-site study designed to develop and
evaluate treatments for adolescent suicide attempters to prevent
reattempts. Participants received state of the art treatment by senior
clinicians. TASA research findings are forthcoming.
NYU Child Study Center -- Department of Child and Adolescent Psychiatry
The NYU Child Study Center is dedicated to increasing the awareness of
child mental health issues and improving the research necessary to advance
the prevention, identification and treatment of mental illness in children
and adolescents on a national scale. The Center offers expert psychiatric
services for children and families with emphasis on early diagnosis and
intervention. The Center's mission is to bridge the gap between science and
practice, integrating the finest research with patient care and
state-of-the-art training, utilizing the resources of the New York
University School of Medicine. The NYU Child Study Center offers a variety
of mental health services for children, adolescents, young adults and their
families. Child and Family Associates is the clinical arm of the NYU Child
Study Center and the point of entry for all clinical programs. Its goal is
to bring together research-supported evaluations and treatments with an
individualized and family-centered approach. The Child Study Center was
founded in 1997 and established as the Department of Child and Adolescent
Psychiatry within the NYU School of Medicine in 2006.
AboutOurKids.
NYU Child Study Center
AboutOurKids
Child Study Center has identified warning signs of depression in teenagers
for parents and tips for helping teens who may be depressed, in light of a
new report from the Centers for Disease Control and Prevention (CDC). The
CDC study, published in the February 2007 issue of Pediatrics finds that
suicide rates in children under 19 years of age increased between 2003 and
2004. Suicide was the only statistically significant increase in child
death over this time. Overall, the suicide rate increased by 18.2 percent
from 2003 to 2004, an increase largely driven by older teens.
"A teen's statement of a wish to kill him/herself must be taken
seriously," said Lori Evans, Ph.D., Director of Psychology Training and the
Project Coordinator of TASA (Treatment of Adolescent Suicide Attempters) at
the NYU Child Study Center. "Before they actually commit or attempt
suicide, teens often make direct statements about their intention to end
their lives, or less direct statements about how they might as well be dead
or that their friends and family would be better off without them."
"Discussing the problem does not encourage the teenager to go through
with the plan," emphasizes Dr. Evans. "On the contrary, it will help him or
her know that someone is willing to be a friend. It may save your
adolescent's life."
Watch for symptoms of depression lasting longer than two weeks, which
may include:
-- A change in eating and sleeping habits
-- A marked personality change, exhibiting angry actions or rebellious
behavior or withdrawal from friends and regular activities
-- Involvement in drugs or alcohol or other risky behaviors such as
reckless driving
-- An overreaction to a recent humiliating experience
-- Difficulty in concentrating and a decline in the quality of school work
-- Persistent boredom and/or lethargy
-- Unusual neglect of appearance
-- Complaints about physical symptoms such as headaches and fatigue
-- A pattern of giving away or throwing away possessions
-- Intolerance of praise or rewards
-- Preoccupation with death in writing songs or poems
-- An increase in comments such as "I can't take it anymore" or "nobody
cares; I wish I was dead"
How to help
-- Take person's comments regarding self-hate, suicide, or death very
seriously
-- Don't try to convince the person to not feel bad. Don't tell them to
"snap out of it" or say "don't feel bad"
-- Keep in close contact with the person and their parent, teacher, or a
good friend
-- Ask the child or teen what you could do that would be helpful to them
-- Don't promise to keep any information a secret
-- If symptoms persist or are dangerous and interfere with daily
functioning, consult a mental health professional immediately
Dr. Lori Evans is the Coordinator of TASA (Treatment of Adolescent
Suicide Attempters) and the Director of Psychology Training at the NYU
Child Study Center. TASA is a multi-site study designed to develop and
evaluate treatments for adolescent suicide attempters to prevent
reattempts. Participants received state of the art treatment by senior
clinicians. TASA research findings are forthcoming.
NYU Child Study Center -- Department of Child and Adolescent Psychiatry
The NYU Child Study Center is dedicated to increasing the awareness of
child mental health issues and improving the research necessary to advance
the prevention, identification and treatment of mental illness in children
and adolescents on a national scale. The Center offers expert psychiatric
services for children and families with emphasis on early diagnosis and
intervention. The Center's mission is to bridge the gap between science and
practice, integrating the finest research with patient care and
state-of-the-art training, utilizing the resources of the New York
University School of Medicine. The NYU Child Study Center offers a variety
of mental health services for children, adolescents, young adults and their
families. Child and Family Associates is the clinical arm of the NYU Child
Study Center and the point of entry for all clinical programs. Its goal is
to bring together research-supported evaluations and treatments with an
individualized and family-centered approach. The Child Study Center was
founded in 1997 and established as the Department of Child and Adolescent
Psychiatry within the NYU School of Medicine in 2006.
AboutOurKids.
NYU Child Study Center
AboutOurKids
воскресенье, 24 апреля 2011 г.
Parents And Researchers To Receive Top Honors At International Conference On Bipolar Disorder
At the 8th International Conference on Bipolar Disorder this week in Pittsburgh, four distinguished individuals will be honored for their contributions to bipolar disorder research, education and service. The conference is the only venue in the world devoted exclusively to highlighting new research into bipolar disorder
Joyce and Dusty Sang will receive the Mogens Schou Award for Public Service for founding The Ryan Licht Sang Bipolar Foundation, in memory of their only son, Ryan, who had early-onset bipolar disorder and died at the age of 24 in 2004. The foundation's mission is to foster awareness, understanding and research for child and adolescent bipolar disorder. One of its major initiatives is a "Quest For The Test™" to find an empirical test for bipolar disorder so that early detection and intervention become a reality.
Lakshmi N. Yatham, M.B.B.S., F.R.C.P.C., M.R.C.Psych. (U.K.), will receive the Mogens Schou Award for Education and Advocacy. Dr. Yatham is a professor of psychiatry and associate head for research and international affairs in the Department of Psychiatry, University of British Columbia, Vancouver, where his research focuses on neurobiology and treatment of bipolar disorder and major depression. Dr. Yatham leads a Canadian consortium on bipolar disorder, which is pursuing testing of new treatments for bipolar disorder. He also is chair of the bipolar group of the Canadian Network for Mood and Anxiety Treatments and is actively involved at a national and international level in continuing medical and public education on diagnosis and treatment of bipolar disorder.
Guy Goodwin, D.Phil., F.Med.Sci., will receive the Mogens Schou Award for Research. Dr. Goodwin is the head of the Department of Psychiatry, Oxford University, where his research focuses on the treatment of severe psychiatric illness and the application of neuroscience in understanding the neurobiology of mood disorders. Dr. Goodwin is researching the neurobiology of vulnerability to mood disorders and the psychopharmacology of emotional processing. He also has helped develop the basis for larger-scale clinical trials in bipolar affective disorder (BALANCE and CEQUEL).
"This year's Mogens Schou Awards continue the strong tradition of honoring those heroes who are making major advances that bring hope to those suffering from bipolar disorder," said David J. Kupfer, M.D., the Thomas P. Detre Professor and chairman, Department of Psychiatry, University of Pittsburgh School of Medicine.
The Mogens Schou Awards were named in recognition and appreciation of Mogens Schou, M.D., Dr. Med. Sci., honorary president, International Society of Bipolar Disorders, and emeritus professor, The Psychiatric Hospital, Risskov, Denmark. His groundbreaking research over 50 years ago proved lithium's significant mood stabilizing effects for the treatment of bipolar disorders. The awards ceremony takes place at 8:30 p.m., Friday, June 26, at The Carnegie Museums of Pittsburgh in Oakland.
The Eighth International Conference on Bipolar Disorder, which is being sponsored by the University of Pittsburgh School of Medicine and Western Psychiatric Institute and Clinic of UPMC, is the only venue in the world devoted exclusively to highlighting new research into bipolar disorder. The disease affects both adults and children, devastates families and work relationships, accounts for nearly half of all suicides in the United States, and costs billions in medical bills, missed work and lower productivity.
Joyce and Dusty Sang will receive the Mogens Schou Award for Public Service for founding The Ryan Licht Sang Bipolar Foundation, in memory of their only son, Ryan, who had early-onset bipolar disorder and died at the age of 24 in 2004. The foundation's mission is to foster awareness, understanding and research for child and adolescent bipolar disorder. One of its major initiatives is a "Quest For The Test™" to find an empirical test for bipolar disorder so that early detection and intervention become a reality.
Lakshmi N. Yatham, M.B.B.S., F.R.C.P.C., M.R.C.Psych. (U.K.), will receive the Mogens Schou Award for Education and Advocacy. Dr. Yatham is a professor of psychiatry and associate head for research and international affairs in the Department of Psychiatry, University of British Columbia, Vancouver, where his research focuses on neurobiology and treatment of bipolar disorder and major depression. Dr. Yatham leads a Canadian consortium on bipolar disorder, which is pursuing testing of new treatments for bipolar disorder. He also is chair of the bipolar group of the Canadian Network for Mood and Anxiety Treatments and is actively involved at a national and international level in continuing medical and public education on diagnosis and treatment of bipolar disorder.
Guy Goodwin, D.Phil., F.Med.Sci., will receive the Mogens Schou Award for Research. Dr. Goodwin is the head of the Department of Psychiatry, Oxford University, where his research focuses on the treatment of severe psychiatric illness and the application of neuroscience in understanding the neurobiology of mood disorders. Dr. Goodwin is researching the neurobiology of vulnerability to mood disorders and the psychopharmacology of emotional processing. He also has helped develop the basis for larger-scale clinical trials in bipolar affective disorder (BALANCE and CEQUEL).
"This year's Mogens Schou Awards continue the strong tradition of honoring those heroes who are making major advances that bring hope to those suffering from bipolar disorder," said David J. Kupfer, M.D., the Thomas P. Detre Professor and chairman, Department of Psychiatry, University of Pittsburgh School of Medicine.
The Mogens Schou Awards were named in recognition and appreciation of Mogens Schou, M.D., Dr. Med. Sci., honorary president, International Society of Bipolar Disorders, and emeritus professor, The Psychiatric Hospital, Risskov, Denmark. His groundbreaking research over 50 years ago proved lithium's significant mood stabilizing effects for the treatment of bipolar disorders. The awards ceremony takes place at 8:30 p.m., Friday, June 26, at The Carnegie Museums of Pittsburgh in Oakland.
The Eighth International Conference on Bipolar Disorder, which is being sponsored by the University of Pittsburgh School of Medicine and Western Psychiatric Institute and Clinic of UPMC, is the only venue in the world devoted exclusively to highlighting new research into bipolar disorder. The disease affects both adults and children, devastates families and work relationships, accounts for nearly half of all suicides in the United States, and costs billions in medical bills, missed work and lower productivity.
UC San Diego To Lead New Pharmacogenomics Project
An international team, led by University of California, San Diego School of Medicine researchers, has been awarded a $6.5 million grant from the National Institutes of Health (NIH) to study the pharmacogenomics of a key mood-stabilizing drug used to treat bipolar disorder.
The grant expands the NIH's Pharmacogenomics Research Network (PGRN), a long-term, multi-million dollar effort to investigate and fulfill the potential of personalized medicine.
John R. Kelsoe, MD, professor of psychiatry in UC San Diego's School of Medicine, will oversee the 5-year project to better understand the genetic bases of bipolar disorder and one of major drugs used to treat it: lithium.
"In every area of medicine, patients respond differently to medicines and some not at all," said Kelsoe. "In treating psychiatric illnesses, this is particularly problematic because it can take years before a correct diagnosis is made. During that time, a patient might see three or four doctors and go through a series of wrong treatments or no treatment at all."
"The promise of personalized medicine in general and pharmacogenomics specifically is the idea that one day we might be able to, say, take a saliva sample and examine it for genetic markers that indicate how a patient will likely respond to different drugs. Doctors could then prescribe an individualized treatment that had the best chance of working quickly and effectively."
Bipolar disorder is a poorly understood mental illness characterized by alternating episodes of extreme mania and depression. It is thought to have multiple, but still unidentified, causes, including a strong genetic component. The National Institute of Mental Health estimates 5.7 million American adults are affected, with the median age of onset at 25. Extreme cases may feature delusions, hallucinations or suicidal thoughts.
Lithium is the oldest and best known of drugs used to treat bipolar disorder, also known as manic-depressive disorder. In some diagnosed cases, lithium can dramatically improve patients' conditions. "It's effective for as long as it's taken. It helps prevent subsequent episodes. Patients can essentially return to normal lives," said Kelsoe.
The challenge has been to identify early those bipolar disorder patients who will benefit from being treated with lithium - about 20 percent of all diagnosed cases, said Kelsoe. The UC San Diego-led study is a step in that direction. The study involves ten research partners, with UC San Diego acting as the coordinating center. The other participating institutions are Indiana University, University of Chicago, University of Iowa, University of Pennsylvania, Johns Hopkins University, University of Michigan, the Translational Genomics Institute in Phoenix, Case Western Reserve University, University of Bergen in Norway, and Dalhouise University in Canada.
Research plans call for diagnosing and treating with lithium a total of 700 patients at the ten sites, following the patients' progress for two years, with a particular emphasis on noting the occurrence of any relapses and the period of time it takes to recover. At the same time, researchers will examine patients' genomes for DNA markers that could ultimately be used to predict how and why some people respond to lithium treatment and others do not.
"If we can identify key genetic markers, then patients can receive the appropriate treatment sooner, and get better faster," said Kelsoe.
Another aspect of the project is to develop a better, deeper understanding of how lithium actually works. "The reality is that we just don't understand a lot of the biology involved," said Kelsoe. "Lithium works, but we don't really know why."
Collaborating with scientists at the Salk Institute for Biological Studies, Kelsoe and colleagues will study stem cells derived from patients' skin biopsies that have been reprogrammed to become neurons. They will look to see how lithium and other drugs interact with the neurons at a cellular level.
"The discoveries we make could help us improve lithium as an effective drug, or even provide new insights for the development of other drugs and therapies," said Kelsoe.
About the PGRN
Spearheaded by the NIH's National Institute of General Medical Sciences (NIGMS) and launched in 2000, the Pharmacogenomics Research Network consists of 14 research groups and five resource development groups. The former investigate genetic questions related to diseases and disorders as varied as mental illness, cancer, asthma, nicotine addiction, heart disease and rheumatoid arthritis. The latter provide DNA sequencing capacity, statistical analysis expertise, and standardized terminology for pharmacogenomics research.
Source:
University of California, San Diego Health Sciences
The grant expands the NIH's Pharmacogenomics Research Network (PGRN), a long-term, multi-million dollar effort to investigate and fulfill the potential of personalized medicine.
John R. Kelsoe, MD, professor of psychiatry in UC San Diego's School of Medicine, will oversee the 5-year project to better understand the genetic bases of bipolar disorder and one of major drugs used to treat it: lithium.
"In every area of medicine, patients respond differently to medicines and some not at all," said Kelsoe. "In treating psychiatric illnesses, this is particularly problematic because it can take years before a correct diagnosis is made. During that time, a patient might see three or four doctors and go through a series of wrong treatments or no treatment at all."
"The promise of personalized medicine in general and pharmacogenomics specifically is the idea that one day we might be able to, say, take a saliva sample and examine it for genetic markers that indicate how a patient will likely respond to different drugs. Doctors could then prescribe an individualized treatment that had the best chance of working quickly and effectively."
Bipolar disorder is a poorly understood mental illness characterized by alternating episodes of extreme mania and depression. It is thought to have multiple, but still unidentified, causes, including a strong genetic component. The National Institute of Mental Health estimates 5.7 million American adults are affected, with the median age of onset at 25. Extreme cases may feature delusions, hallucinations or suicidal thoughts.
Lithium is the oldest and best known of drugs used to treat bipolar disorder, also known as manic-depressive disorder. In some diagnosed cases, lithium can dramatically improve patients' conditions. "It's effective for as long as it's taken. It helps prevent subsequent episodes. Patients can essentially return to normal lives," said Kelsoe.
The challenge has been to identify early those bipolar disorder patients who will benefit from being treated with lithium - about 20 percent of all diagnosed cases, said Kelsoe. The UC San Diego-led study is a step in that direction. The study involves ten research partners, with UC San Diego acting as the coordinating center. The other participating institutions are Indiana University, University of Chicago, University of Iowa, University of Pennsylvania, Johns Hopkins University, University of Michigan, the Translational Genomics Institute in Phoenix, Case Western Reserve University, University of Bergen in Norway, and Dalhouise University in Canada.
Research plans call for diagnosing and treating with lithium a total of 700 patients at the ten sites, following the patients' progress for two years, with a particular emphasis on noting the occurrence of any relapses and the period of time it takes to recover. At the same time, researchers will examine patients' genomes for DNA markers that could ultimately be used to predict how and why some people respond to lithium treatment and others do not.
"If we can identify key genetic markers, then patients can receive the appropriate treatment sooner, and get better faster," said Kelsoe.
Another aspect of the project is to develop a better, deeper understanding of how lithium actually works. "The reality is that we just don't understand a lot of the biology involved," said Kelsoe. "Lithium works, but we don't really know why."
Collaborating with scientists at the Salk Institute for Biological Studies, Kelsoe and colleagues will study stem cells derived from patients' skin biopsies that have been reprogrammed to become neurons. They will look to see how lithium and other drugs interact with the neurons at a cellular level.
"The discoveries we make could help us improve lithium as an effective drug, or even provide new insights for the development of other drugs and therapies," said Kelsoe.
About the PGRN
Spearheaded by the NIH's National Institute of General Medical Sciences (NIGMS) and launched in 2000, the Pharmacogenomics Research Network consists of 14 research groups and five resource development groups. The former investigate genetic questions related to diseases and disorders as varied as mental illness, cancer, asthma, nicotine addiction, heart disease and rheumatoid arthritis. The latter provide DNA sequencing capacity, statistical analysis expertise, and standardized terminology for pharmacogenomics research.
Source:
University of California, San Diego Health Sciences
суббота, 23 апреля 2011 г.
Repligen Initiates Phase 2 Clinical Trial Of RG2417 For Bipolar Depression
Repligen Corporation
(Nasdaq: RGEN) today announced that the Company has initiated a Phase 2
clinical trial of RG2417, an oral formulation of uridine, in patients with
bipolar depression. This Phase 2 study is a multi-center, dose escalating
study in which 80 patients will receive either RG2417 or a placebo for 6
weeks. Patients will be evaluated for the safety and effectiveness of RG2417
on the symptoms of bipolar depression. This study is being conducted under a
development agreement with the Stanley Medical Research Institute, under which
Repligen will receive approximately $1,000,000 in funding. The Stanley
Medical Research Institute is the largest nonprofit provider of funding for
research on schizophrenia and bipolar disorder in the United States.
"Bipolar depression is a serious chronic illness and treatment is
challenging due to the potential for induction of mania, a common side effect
of standard treatment with antidepressants," stated Walter C. Herlihy,
President and Chief Executive Officer of Repligen. "If this proof of
principle study shows evidence that RG2417 improves the symptoms of bipolar
depression without inducing mania, it has the potential to be an important new
therapy in an area of significant unmet medical need."
Repligen previously completed a 6-week Phase 1 clinical trial of a prodrug
of uridine (RG2133) in patients with bipolar disorder or major depression.
The results demonstrated that administration of RG2133 in this patient
population appeared to be safe, did not induce mania, and provided early
evidence of a clinical effect of the drug. The trial evaluated 19 patients
and was carried out by investigators at McLean Hospital, the largest
psychiatric clinical care, teaching and research affiliate of Harvard Medical
School.
Uridine is a biological compound essential for the synthesis of DNA and
RNA, the basic hereditary material found in all cells, and numerous other
factors essential for cell metabolism. Uridine is synthesized by the power
plant of the human cell known as the mitochondria. The rationale for uridine
therapy in neuropsychiatric disorders is supported by pre-clinical and
clinical research. Researchers at McLean Hospital previously demonstrated
that uridine is active in a well-validated animal model of depression. Recent
reports indicate that certain genes that encode for mitochondrial proteins are
significantly down-regulated in the brains of bipolar patients. This new
insight suggests that the symptoms of bipolar disorder may be linked to
dysregulation of energy metabolism of the brain.
About Bipolar Disorder
Bipolar disorder, also known as manic depression, is an illness marked by
extreme changes in mood, thought, energy and behavior in which a person's mood
can alternate between the "poles" of mania (highs) and depression (lows).
Bipolar disorder affects more than two million adults in the United States and
is usually diagnosed in late adolescence or early adulthood. Bipolar disorder
is a chronic illness associated with substantial morbidity and mortality,
ranking worldwide behind only unipolar depression and alcohol abuse among
psychiatric illnesses for related disabilities and overall economic burden of
illness. The lifetime financial burden of bipolar disorder in the United
States is about $625,000 per patient, depending on resistance to treatment and
persistence of symptoms. Although lithium and anticonvulsants such as
valproic acid have substantially improved the prognosis of bipolar disorder,
many individuals are unable to tolerate treatment-related side effects, and
incomplete clinical response, relapse, and recurrence remain common clinical
problems.
About The Stanley Medical Research Institute
The Stanley Medical Research Institute (SMRI) is a nonprofit organization
that supports research on the causes and treatment of schizophrenia and
bipolar disorder (manic-depressive illness), both through work carried out in
its own laboratories and through support of researchers worldwide who are
working on these diseases. SMRI is the largest nonprofit provider of research
funding for schizophrenia and bipolar disorder in the United States and has
provided over $200 million in funding since 1999. SMRI funds approximately
half of all U.S. research on bipolar disorder and approximately one quarter of
the research on schizophrenia. Schizophrenia and bipolar disorder are the
major psychiatric disorders in the United States, affecting more than 4
million people.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company committed to being the
leader in the development of novel therapeutics for profound neuropsychiatric
disorders and autoimmune disease. Repligen has a Specialty Pharmaceuticals
business comprised of rProtein A(TM) and SecreFlo(R), the profits from which
will be used to partially support the development of our proprietary products.
Repligen's corporate headquarters are located at 41 Seyon Street, Building #1,
Suite 100, Waltham, MA 02453. Additional information may be requested from
repligen.
This press release contains forward-looking statements which are made
pursuant to the safe harbor provisions of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. The forward-looking statements in this release do not constitute
guarantees of future performance. Investors are cautioned that statements in
this press release which are not strictly historical statements, including,
without limitation, statements regarding current or future financial
performance and position, management's strategy, plans and objectives for
future operations, plans and objectives for product development, plans and
objectives for present and future clinical trials and results of such trials,
plans and objectives for regulatory approval, litigation, intellectual
property, product development, manufacturing plans and performance such as the
anticipated growth in the monoclonal antibody market and our other target
markets and projected growth in product sales, constitute forward-looking
statements. Such forward-looking statements are subject to a number of risks
and uncertainties that could cause actual results to differ materially from
those anticipated, including, without limitation, risks associated with: the
success of current and future collaborative relationships, the market
acceptance of our products, our ability to compete with larger, better
financed pharmaceutical and biotechnology companies, new approaches to the
treatment of our targeted diseases, our expectation of incurring continued
losses, our uncertainty of product revenues and profits, our ability to
generate future revenues, our ability to raise additional capital to continue
our drug development programs, the success of our clinical trials, our ability
to develop and commercialize products, our ability to obtain required
regulatory approvals, our compliance with all Food and Drug Administration
regulations, our ability to obtain, maintain and protect intellectual property
rights for our products, the risk of litigation regarding our intellectual
property rights, our limited sales and manufacturing capabilities, our
dependence on third-party manufacturers and value added resellers, our ability
to hire and retain skilled personnel, our volatile stock price, and other
risks detailed in Repligen's filings with the Securities and Exchange
Commission. Repligen assumes no obligation to update any forward-looking
information contained in this press release or with respect to the
announcements described herein.
Repligen Corporation
(Nasdaq: RGEN) today announced that the Company has initiated a Phase 2
clinical trial of RG2417, an oral formulation of uridine, in patients with
bipolar depression. This Phase 2 study is a multi-center, dose escalating
study in which 80 patients will receive either RG2417 or a placebo for 6
weeks. Patients will be evaluated for the safety and effectiveness of RG2417
on the symptoms of bipolar depression. This study is being conducted under a
development agreement with the Stanley Medical Research Institute, under which
Repligen will receive approximately $1,000,000 in funding. The Stanley
Medical Research Institute is the largest nonprofit provider of funding for
research on schizophrenia and bipolar disorder in the United States.
"Bipolar depression is a serious chronic illness and treatment is
challenging due to the potential for induction of mania, a common side effect
of standard treatment with antidepressants," stated Walter C. Herlihy,
President and Chief Executive Officer of Repligen. "If this proof of
principle study shows evidence that RG2417 improves the symptoms of bipolar
depression without inducing mania, it has the potential to be an important new
therapy in an area of significant unmet medical need."
Repligen previously completed a 6-week Phase 1 clinical trial of a prodrug
of uridine (RG2133) in patients with bipolar disorder or major depression.
The results demonstrated that administration of RG2133 in this patient
population appeared to be safe, did not induce mania, and provided early
evidence of a clinical effect of the drug. The trial evaluated 19 patients
and was carried out by investigators at McLean Hospital, the largest
psychiatric clinical care, teaching and research affiliate of Harvard Medical
School.
Uridine is a biological compound essential for the synthesis of DNA and
RNA, the basic hereditary material found in all cells, and numerous other
factors essential for cell metabolism. Uridine is synthesized by the power
plant of the human cell known as the mitochondria. The rationale for uridine
therapy in neuropsychiatric disorders is supported by pre-clinical and
clinical research. Researchers at McLean Hospital previously demonstrated
that uridine is active in a well-validated animal model of depression. Recent
reports indicate that certain genes that encode for mitochondrial proteins are
significantly down-regulated in the brains of bipolar patients. This new
insight suggests that the symptoms of bipolar disorder may be linked to
dysregulation of energy metabolism of the brain.
About Bipolar Disorder
Bipolar disorder, also known as manic depression, is an illness marked by
extreme changes in mood, thought, energy and behavior in which a person's mood
can alternate between the "poles" of mania (highs) and depression (lows).
Bipolar disorder affects more than two million adults in the United States and
is usually diagnosed in late adolescence or early adulthood. Bipolar disorder
is a chronic illness associated with substantial morbidity and mortality,
ranking worldwide behind only unipolar depression and alcohol abuse among
psychiatric illnesses for related disabilities and overall economic burden of
illness. The lifetime financial burden of bipolar disorder in the United
States is about $625,000 per patient, depending on resistance to treatment and
persistence of symptoms. Although lithium and anticonvulsants such as
valproic acid have substantially improved the prognosis of bipolar disorder,
many individuals are unable to tolerate treatment-related side effects, and
incomplete clinical response, relapse, and recurrence remain common clinical
problems.
About The Stanley Medical Research Institute
The Stanley Medical Research Institute (SMRI) is a nonprofit organization
that supports research on the causes and treatment of schizophrenia and
bipolar disorder (manic-depressive illness), both through work carried out in
its own laboratories and through support of researchers worldwide who are
working on these diseases. SMRI is the largest nonprofit provider of research
funding for schizophrenia and bipolar disorder in the United States and has
provided over $200 million in funding since 1999. SMRI funds approximately
half of all U.S. research on bipolar disorder and approximately one quarter of
the research on schizophrenia. Schizophrenia and bipolar disorder are the
major psychiatric disorders in the United States, affecting more than 4
million people.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company committed to being the
leader in the development of novel therapeutics for profound neuropsychiatric
disorders and autoimmune disease. Repligen has a Specialty Pharmaceuticals
business comprised of rProtein A(TM) and SecreFlo(R), the profits from which
will be used to partially support the development of our proprietary products.
Repligen's corporate headquarters are located at 41 Seyon Street, Building #1,
Suite 100, Waltham, MA 02453. Additional information may be requested from
repligen.
This press release contains forward-looking statements which are made
pursuant to the safe harbor provisions of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. The forward-looking statements in this release do not constitute
guarantees of future performance. Investors are cautioned that statements in
this press release which are not strictly historical statements, including,
without limitation, statements regarding current or future financial
performance and position, management's strategy, plans and objectives for
future operations, plans and objectives for product development, plans and
objectives for present and future clinical trials and results of such trials,
plans and objectives for regulatory approval, litigation, intellectual
property, product development, manufacturing plans and performance such as the
anticipated growth in the monoclonal antibody market and our other target
markets and projected growth in product sales, constitute forward-looking
statements. Such forward-looking statements are subject to a number of risks
and uncertainties that could cause actual results to differ materially from
those anticipated, including, without limitation, risks associated with: the
success of current and future collaborative relationships, the market
acceptance of our products, our ability to compete with larger, better
financed pharmaceutical and biotechnology companies, new approaches to the
treatment of our targeted diseases, our expectation of incurring continued
losses, our uncertainty of product revenues and profits, our ability to
generate future revenues, our ability to raise additional capital to continue
our drug development programs, the success of our clinical trials, our ability
to develop and commercialize products, our ability to obtain required
regulatory approvals, our compliance with all Food and Drug Administration
regulations, our ability to obtain, maintain and protect intellectual property
rights for our products, the risk of litigation regarding our intellectual
property rights, our limited sales and manufacturing capabilities, our
dependence on third-party manufacturers and value added resellers, our ability
to hire and retain skilled personnel, our volatile stock price, and other
risks detailed in Repligen's filings with the Securities and Exchange
Commission. Repligen assumes no obligation to update any forward-looking
information contained in this press release or with respect to the
announcements described herein.
Repligen Corporation
пятница, 22 апреля 2011 г.
First study to show SEROQUEL may be effective in rapid-cycling bipolar disorder
New data shows SEROQUEL works quickly and is well-tolerated in a difficult to treat patient population
Alderley Park, UK - September 24, 2004 - AstraZeneca announced important new data presented today at the 4th European Stanley Foundation Conference on Bipolar Disorder, which show SEROQUEL is significantly more effective than placebo in treating patients with rapid-cycling bipolar disorder and is also well-tolerated in this difficult to treat patient population.1 The results are from the first large-scale, placebo-controlled study of an atypical antipsychotic in the treatment of bipolar I or II depression including patients with rapid-cycling.
Rapid-cycling affects up to one in five people with bipolar disorder and is characterised by the occurrence of four or more episodes of depression, mania or hypomania, cycling within 12 months.2 Patients with rapid-cycling often experience more severe symptoms of depression and are more difficult to treat than non rapid-cycling patients.3
The results show SEROQUEL provided greater effective relief from core symptoms of depression, such as sadness, pessimistic thoughts and suicidal thoughts, than placebo from as early as week one with symptom improvement continuing throughout the 8-week trial. Importantly, this trial also found SEROQUEL was not associated with significant treatment-emergent mania which can occur with other treatments for this condition such as antidepressants.1,2
"Treating depressive episodes in patients who have a rapid-cycling course can be very difficult due to the increased severity and frequency of their symptoms, putting them at greater risk of hospitalisation or suicide," commented Dr. Eduard Vieta, Director of the Bipolar Disorders Program of the Hospital Clinic, University of Barcelona, Spain. "This new data is the first step forward in providing a solution to an urgent medical need and suggests Seroquel could be an important new treatment option for this devastating condition."
The 8-week, double-blind, placebo-controlled study, a subanalysis of patients from a larger SEROQUEL trial known as BOLDER, randomised 108 patients with bipolar I or II disorder exhibiting moderate to severe depression and experiencing a rapid-cycling disease course, to receive SEROQUEL at 300mg/day, SEROQUEL at 600mg/day or placebo. The results of the subanalysis showed patients treated with SEROQUEL experienced:
-- a significantly (p
-- -- minimal changes on the Young Mania Rating Scale (YMRS) throughout treatment, with no difference between groups in mean change from baseline to week 8 (+0.1, -1.1, -0.8 for SEROQUEL 600mg/day, SEROQUEL 300mg/day and placebo respectively)
-- treatment-emergent mania was low and similar across each group (two patients for each SEROQUEL arm and one patient on placebo)
-- a low incidence of EPS including akathisia and parkinsonian symptoms and minimal weight change (none of which led to any patient withdrawals).
In addition, new data presented today from the BOLDER trial show that SEROQUEL is effective in reducing the time to treatment response in patients with bipolar depression.4 An 8-week, double-blind, randomised trial involving 542 patients with a diagnosis of bipolar I or bipolar II disorder exhibiting moderate to severe depression found SEROQUEL (300mg/day or 600mg/day) significantly reduces the time taken for patients to respond to their treatment and achieve remission from their symptoms compared to placebo. The results of the trial found that with SEROQUEL:
-- significantly more patients receiving SEROQUEL classified as responders at the final assessment (week 8) compared to placebo.
Alderley Park, UK - September 24, 2004 - AstraZeneca announced important new data presented today at the 4th European Stanley Foundation Conference on Bipolar Disorder, which show SEROQUEL is significantly more effective than placebo in treating patients with rapid-cycling bipolar disorder and is also well-tolerated in this difficult to treat patient population.1 The results are from the first large-scale, placebo-controlled study of an atypical antipsychotic in the treatment of bipolar I or II depression including patients with rapid-cycling.
Rapid-cycling affects up to one in five people with bipolar disorder and is characterised by the occurrence of four or more episodes of depression, mania or hypomania, cycling within 12 months.2 Patients with rapid-cycling often experience more severe symptoms of depression and are more difficult to treat than non rapid-cycling patients.3
The results show SEROQUEL provided greater effective relief from core symptoms of depression, such as sadness, pessimistic thoughts and suicidal thoughts, than placebo from as early as week one with symptom improvement continuing throughout the 8-week trial. Importantly, this trial also found SEROQUEL was not associated with significant treatment-emergent mania which can occur with other treatments for this condition such as antidepressants.1,2
"Treating depressive episodes in patients who have a rapid-cycling course can be very difficult due to the increased severity and frequency of their symptoms, putting them at greater risk of hospitalisation or suicide," commented Dr. Eduard Vieta, Director of the Bipolar Disorders Program of the Hospital Clinic, University of Barcelona, Spain. "This new data is the first step forward in providing a solution to an urgent medical need and suggests Seroquel could be an important new treatment option for this devastating condition."
The 8-week, double-blind, placebo-controlled study, a subanalysis of patients from a larger SEROQUEL trial known as BOLDER, randomised 108 patients with bipolar I or II disorder exhibiting moderate to severe depression and experiencing a rapid-cycling disease course, to receive SEROQUEL at 300mg/day, SEROQUEL at 600mg/day or placebo. The results of the subanalysis showed patients treated with SEROQUEL experienced:
-- a significantly (p
-- -- minimal changes on the Young Mania Rating Scale (YMRS) throughout treatment, with no difference between groups in mean change from baseline to week 8 (+0.1, -1.1, -0.8 for SEROQUEL 600mg/day, SEROQUEL 300mg/day and placebo respectively)
-- treatment-emergent mania was low and similar across each group (two patients for each SEROQUEL arm and one patient on placebo)
-- a low incidence of EPS including akathisia and parkinsonian symptoms and minimal weight change (none of which led to any patient withdrawals).
In addition, new data presented today from the BOLDER trial show that SEROQUEL is effective in reducing the time to treatment response in patients with bipolar depression.4 An 8-week, double-blind, randomised trial involving 542 patients with a diagnosis of bipolar I or bipolar II disorder exhibiting moderate to severe depression found SEROQUEL (300mg/day or 600mg/day) significantly reduces the time taken for patients to respond to their treatment and achieve remission from their symptoms compared to placebo. The results of the trial found that with SEROQUEL:
-- significantly more patients receiving SEROQUEL classified as responders at the final assessment (week 8) compared to placebo.
четверг, 21 апреля 2011 г.
NICE Consults On Draft Recommendations For Psychosis With Co-Existing Substance Misuse
NICE is currently developing a clinical guideline on the assessment and management of psychosis with co-existing substance misuse in adults and young people. As part of this process, draft recommendations have been published on the NICE website for public consultation.
Psychosis is used to describe a group of severe mental health disorders characterised by the presence of delusions and hallucinations that disrupt a person's perception, thoughts, emotions and behaviour. The main forms of psychosis are schizophrenia, bipolar disorder or other affective psychoses.
Dr Fergus Macbeth, Director of the Centre for Clinical Practice at NICE, said:
"Approximately 40% of people who have been diagnosed with psychosis have also misused a substance at some point in their lifetime. This is at least double the rate seen in the general population. When these two conditions co-exist, patients can spend twice as long in hospital, compared with those who do not misuse substances. They experience poorer physical health, are less likely to take prescribed medication and more likely to 'drop out' of services. However, less than a fifth of people who have coexisting psychosis and substance misuse receive treatment for their substance misuse.
"The aim of this guideline is to help ensure that people diagnosed with a form of psychosis who also misuse substances can be identified and treated effectively for both conditions. The draft recommendations are now available for public consultation. Anyone wishing to submit comments should visit our website for more information on the consultation process."
Draft recommendations issued for consultation include:
Recognition of psychosis with coexisting substance misuse in adults and young people: Healthcare professionals in all healthcare settings, including primary care, secondary mental health care services, CAMHS and accident and emergency departments, and those in prisons and criminal justice mental health liaison schemes, should routinely ask adults and young people with known or suspected psychosis about their use of alcohol and/or prescribed and non-prescribed (including illicit) drugs.
Secondary care mental health services:
1.Do not exclude adults and young people with psychosis and coexisting substance misuse from age-appropriate mental healthcare because of their substance misuse.
2.Do not exclude adults and young people with psychosis and coexisting substance misuse from age-appropriate substance misuse services because of a diagnosis of psychosis.
Substance misuse services: Healthcare professionals working in substance misuse services should be competent to: recognise the signs and symptoms of psychosis; undertake a full mental health needs and risk assessment; know how and when to refer to secondary mental health services.
Inpatient mental health services: All inpatient services should ensure that they have policies and procedures for promoting a therapeutic environment free from drugs and alcohol that have been developed together with service users and carers. These should include: search procedures, visiting arrangements, planning and reviewing leave, drug and alcohol testing, disposal of legal and illicit substances, and other security measures. Soon after admission, provide all service users, and their families, carers and significant others, with information about the policies and procedures.
Specific issues for young people with psychosis and coexisting substance misuse: Those providing and commissioning services should ensure that:
1.age-appropriate mental health services are available for young people with psychosis and coexisting substance misuse and
2.transition arrangements to adult mental health services are in place where appropriate.
Notes
About the guidance
1. The draft guidance will be available on the NICE website from 10 August, 2010.
2. In the UK, the annual prevalence for probable psychotic disorder among adults living in private households is about 5 per 1000.
Among those diagnosed with a psychotic disorder, studies show that prevalence for any substance misuse ranges from 24-36% (7-20% for alcohol misuse only, 5-9% for drug misuse only, 8% for drug and alcohol misuse).
Psychosis is used to describe a group of severe mental health disorders characterised by the presence of delusions and hallucinations that disrupt a person's perception, thoughts, emotions and behaviour. The main forms of psychosis are schizophrenia, bipolar disorder or other affective psychoses.
Dr Fergus Macbeth, Director of the Centre for Clinical Practice at NICE, said:
"Approximately 40% of people who have been diagnosed with psychosis have also misused a substance at some point in their lifetime. This is at least double the rate seen in the general population. When these two conditions co-exist, patients can spend twice as long in hospital, compared with those who do not misuse substances. They experience poorer physical health, are less likely to take prescribed medication and more likely to 'drop out' of services. However, less than a fifth of people who have coexisting psychosis and substance misuse receive treatment for their substance misuse.
"The aim of this guideline is to help ensure that people diagnosed with a form of psychosis who also misuse substances can be identified and treated effectively for both conditions. The draft recommendations are now available for public consultation. Anyone wishing to submit comments should visit our website for more information on the consultation process."
Draft recommendations issued for consultation include:
Recognition of psychosis with coexisting substance misuse in adults and young people: Healthcare professionals in all healthcare settings, including primary care, secondary mental health care services, CAMHS and accident and emergency departments, and those in prisons and criminal justice mental health liaison schemes, should routinely ask adults and young people with known or suspected psychosis about their use of alcohol and/or prescribed and non-prescribed (including illicit) drugs.
Secondary care mental health services:
1.Do not exclude adults and young people with psychosis and coexisting substance misuse from age-appropriate mental healthcare because of their substance misuse.
2.Do not exclude adults and young people with psychosis and coexisting substance misuse from age-appropriate substance misuse services because of a diagnosis of psychosis.
Substance misuse services: Healthcare professionals working in substance misuse services should be competent to: recognise the signs and symptoms of psychosis; undertake a full mental health needs and risk assessment; know how and when to refer to secondary mental health services.
Inpatient mental health services: All inpatient services should ensure that they have policies and procedures for promoting a therapeutic environment free from drugs and alcohol that have been developed together with service users and carers. These should include: search procedures, visiting arrangements, planning and reviewing leave, drug and alcohol testing, disposal of legal and illicit substances, and other security measures. Soon after admission, provide all service users, and their families, carers and significant others, with information about the policies and procedures.
Specific issues for young people with psychosis and coexisting substance misuse: Those providing and commissioning services should ensure that:
1.age-appropriate mental health services are available for young people with psychosis and coexisting substance misuse and
2.transition arrangements to adult mental health services are in place where appropriate.
Notes
About the guidance
1. The draft guidance will be available on the NICE website from 10 August, 2010.
2. In the UK, the annual prevalence for probable psychotic disorder among adults living in private households is about 5 per 1000.
Among those diagnosed with a psychotic disorder, studies show that prevalence for any substance misuse ranges from 24-36% (7-20% for alcohol misuse only, 5-9% for drug misuse only, 8% for drug and alcohol misuse).
среда, 20 апреля 2011 г.
12-Fold Increase Of Suicide Risk In People With Severe Mental Illness
People with psychotic disorders, such as schizophrenia or bipolar disorder, are 12 times more likely to commit suicide than average, according to research released by King's Health Partners.
The research found that the rate of suicide was highest in the first year following diagnosis (12 times national average) and that high risk persisted - remaining four times greater than the general population ten years after diagnosis, a time when there may be less intense clinical monitoring of risk.
Neither the risk of suicide nor the long-term risk of suicide, as compared to the general population, have been studied and measured in this way before. And the findings show that doctors must always remain vigilant when assessing a patient's risk of suicide regardless of time since first diagnosis.
A key aim of the study was to challenge the widely held view that "10-15% of people suffering psychotic disorders are likely to commit suicide"┬╣. This study shows that these figures, largely derived from research in the 1970s, are misleading as they use crude measurement techniques┬▓ and do not accurately measure risk over a lifetime. Today's findings indicate a lower overall risk, but more persistent danger of suicide among this patient group over a lifetime.
Dr Rina Dutta, MRC Research Fellow and Honorary Consultant Psychiatrist, King's Health Partners, said: "It's well known that people who commit suicide often suffer serious mental health problems, but it's surprising that the risk they face remains so high ten years or more after first diagnosis. Putting a figure on it like this helps doctors to understand the extent of risk some of their patients face."
The research studied a group of almost 3,000 patients in the UK (London, Nottingham and Dumfries and Galloway) who suffered their first psychotic illness between 1965 and 2004. The patients were traced after an average follow-up time of 11.5 years and their death certificates were analysed.
People with psychotic disorders experience disturbed thoughts, feelings, mood and behaviours. Psychotic conditions tend to strike when people are young and affect one in 50 of the UK population.
Notes:
Reassessing the Long-term Risk of Suicide after a First Episode of Psychosis is published in the US journal Archives of General Psychiatry on Monday 6 December 2010.
This study was funded by the Medical Research Council, London, UK, as well as by grants from the British Medical Association, Psychiatry Research Trust, London, UK and the Chief Scientist Office, Scottish Government.
The research found that the rate of suicide was highest in the first year following diagnosis (12 times national average) and that high risk persisted - remaining four times greater than the general population ten years after diagnosis, a time when there may be less intense clinical monitoring of risk.
Neither the risk of suicide nor the long-term risk of suicide, as compared to the general population, have been studied and measured in this way before. And the findings show that doctors must always remain vigilant when assessing a patient's risk of suicide regardless of time since first diagnosis.
A key aim of the study was to challenge the widely held view that "10-15% of people suffering psychotic disorders are likely to commit suicide"┬╣. This study shows that these figures, largely derived from research in the 1970s, are misleading as they use crude measurement techniques┬▓ and do not accurately measure risk over a lifetime. Today's findings indicate a lower overall risk, but more persistent danger of suicide among this patient group over a lifetime.
Dr Rina Dutta, MRC Research Fellow and Honorary Consultant Psychiatrist, King's Health Partners, said: "It's well known that people who commit suicide often suffer serious mental health problems, but it's surprising that the risk they face remains so high ten years or more after first diagnosis. Putting a figure on it like this helps doctors to understand the extent of risk some of their patients face."
The research studied a group of almost 3,000 patients in the UK (London, Nottingham and Dumfries and Galloway) who suffered their first psychotic illness between 1965 and 2004. The patients were traced after an average follow-up time of 11.5 years and their death certificates were analysed.
People with psychotic disorders experience disturbed thoughts, feelings, mood and behaviours. Psychotic conditions tend to strike when people are young and affect one in 50 of the UK population.
Notes:
Reassessing the Long-term Risk of Suicide after a First Episode of Psychosis is published in the US journal Archives of General Psychiatry on Monday 6 December 2010.
This study was funded by the Medical Research Council, London, UK, as well as by grants from the British Medical Association, Psychiatry Research Trust, London, UK and the Chief Scientist Office, Scottish Government.
вторник, 19 апреля 2011 г.
Revealing Lithium's Mode Of Action
Though it has been prescribed for over 50 years to treat bipolar disorder, there are still many questions regarding exactly how lithium works. However, in a study appearing in this month's Journal of Lipid Research, researchers have provided solid evidence that lithium reduces brain inflammation by adjusting the metabolism of the health-protective omega-3-fatty acid called DHA.
Inflammation in the brain, like other parts of the body, is an important process to help the brain combat infection or injury. However, excess or unwanted inflammation can damage sensitive brain cells, which can contribute to psychiatric conditions like bipolar disorder or degenerative diseases like Alzheimers.
It's believed that lithium helps treat bipolar disorder by reducing brain inflammation during the manic phase, thus alleviating some of the symptoms. Exactly how lithium operates, though, has been debated.
Mireille Basselin and colleagues at the National Institute of Aging and University of Colorado, Denver, took a detailed approach to this question by using mass spectrometry analysis to analyze the chemical composition of brain samples of both control and lithium-treated rats stressed by brain inflammation.
They found that in agreement with some other studies, rats given a six-week lithium treatment had reduced levels of arachidonic acid and its products, which can contribute to inflammation.
In addition, they also demonstrated, for the first time, that lithium treatment increased levels of a metabolite called 17-OH-DHA in response to inflammation. 17-OH-DHA is formed from the omega-3 fatty acid DHA (docosahexaenoic acid) and is the precursor to a wide range of anti-inflammatory compounds known as docosanoids. Other anti-inflammatory drugs, like aspirin, are known to also enhance docosanoids in their mode of action.
Basselin and colleagues noted that the concentration of DHA did not increase, which suggests that lithium may increase 17-OH-DHA levels by affecting the enzyme that converts DHA to 17-OH-DHA.
By reducing both pro-inflammatory AA products, and increasing anti-inflammatory DHA products, lithium exerts a double-protective effect which may explain why it works well in bipolar treatment. Now that its mechanism is a little better understood, it may lead to additional uses for this chemical.
From the article: "Lithium modifies brain arachidonic and docosahexaenoic metabolism in rat lipopolysaccharide model of neuroinflammation" by Mireille Basselin, Hyung-Wook Kim, Mei Chen, Kaizong Ma, Stanley I. Rapoport, Robert C. Murphy and Santiago E. Farias
Inflammation in the brain, like other parts of the body, is an important process to help the brain combat infection or injury. However, excess or unwanted inflammation can damage sensitive brain cells, which can contribute to psychiatric conditions like bipolar disorder or degenerative diseases like Alzheimers.
It's believed that lithium helps treat bipolar disorder by reducing brain inflammation during the manic phase, thus alleviating some of the symptoms. Exactly how lithium operates, though, has been debated.
Mireille Basselin and colleagues at the National Institute of Aging and University of Colorado, Denver, took a detailed approach to this question by using mass spectrometry analysis to analyze the chemical composition of brain samples of both control and lithium-treated rats stressed by brain inflammation.
They found that in agreement with some other studies, rats given a six-week lithium treatment had reduced levels of arachidonic acid and its products, which can contribute to inflammation.
In addition, they also demonstrated, for the first time, that lithium treatment increased levels of a metabolite called 17-OH-DHA in response to inflammation. 17-OH-DHA is formed from the omega-3 fatty acid DHA (docosahexaenoic acid) and is the precursor to a wide range of anti-inflammatory compounds known as docosanoids. Other anti-inflammatory drugs, like aspirin, are known to also enhance docosanoids in their mode of action.
Basselin and colleagues noted that the concentration of DHA did not increase, which suggests that lithium may increase 17-OH-DHA levels by affecting the enzyme that converts DHA to 17-OH-DHA.
By reducing both pro-inflammatory AA products, and increasing anti-inflammatory DHA products, lithium exerts a double-protective effect which may explain why it works well in bipolar treatment. Now that its mechanism is a little better understood, it may lead to additional uses for this chemical.
From the article: "Lithium modifies brain arachidonic and docosahexaenoic metabolism in rat lipopolysaccharide model of neuroinflammation" by Mireille Basselin, Hyung-Wook Kim, Mei Chen, Kaizong Ma, Stanley I. Rapoport, Robert C. Murphy and Santiago E. Farias
понедельник, 18 апреля 2011 г.
RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed The Time To Relapse In Patients With Bipolar I Disorder
New data demonstrate that maintenance therapy with RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment (RLAT) significantly delayed the time to relapse compared to placebo in patients with Bipolar I Disorder. Results of the study were presented this week at a major medical meeting.
Bipolar Disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression). Type I Bipolar Disorder is characterized based on the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the American adult population in any given year.
A randomized, double-blind, placebo-controlled, long-term study was conducted to evaluate the effect of RISPERDAL(R) CONSTA(R) as maintenance therapy in patients who met DSM-IV criteria for Bipolar I Disorder who were stable on medications or experiencing an acute manic or mixed episode. In the first phase of the study, 303 patients were stabilized on open-label RISPERDAL(R) CONSTA(R) for 26 weeks. In the double-blind phase, patients were randomized to either maintenance therapy with RISPERDAL(R) CONSTA(R) (N=154) or placebo (N=149). The median duration of treatment was nine months for patients in the RISPERDAL(R) CONSTA(R) group and five months for patients in the placebo group. The primary endpoint was time to relapse of any mood episode (depression, mania, or mixed).
Time to relapse was significantly longer in patients receiving RISPERDAL(R) CONSTA(R) monotherapy as compared to placebo (p
RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment (RLAT) is a long-acting injectable atypical antipsychotic therapy used for the treatment of schizophrenia and the maintenance treatment of Bipolar I Disorder. It was developed utilizing Alkermes' proprietary Medisorb(R) drug-delivery technology. Using this technology, risperidone is encapsulated in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and administered to patients by intramuscular injection once every two weeks. RISPERDAL(R) CONSTA(R) is manufactured by Alkermes, Inc. and marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and Janssen-Cilag outside of the U.S.
About Janssen
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. It currently has prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder.
About J&JPRD
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide.
IMPORTANT SAFETY INFORMATION FOR CONSUMERS ABOUT RISPERDAL(R) CONSTA(R)
Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL(R) CONSTA(R) and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL(R) CONSTA(R) and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
High blood sugar and diabetes have been reported with RISPERDAL(R) CONSTA(R) and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with RISPERDAL(R) CONSTA(R). Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.
RISPERDAL(R) CONSTA(R) and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.
Some people taking RISPERDAL(R) CONSTA(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 healthcare professional's dosing instructions, this side effect can be reduced or it may go away over time.
Problems with the blood have been reported with RISPERDAL(R) CONSTA(R) and similar medications. Depending upon condition your doctor may choose to monitor your blood as you start therapy with RISPERDAL(R) CONSTA.
RISPERDAL(R) CONSTA(R) may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.
RISPERDAL(R) CONSTA(R) should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Painful, long lasting erections have been reported with the use of RISPERDAL(R) CONSTA(R). Call your doctor immediately if you think you are having this problem.
Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.
Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL(R) CONSTA(R). Caution should be exercised when administering RISPERDAL(R) CONSTA(R) to a nursing woman.
RISPERDAL(R) CONSTA(R) may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.
Some medications interact with RISPERDAL(R) CONSTA(R). Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL(R) CONSTA(R).
In a study of people taking RISPERDAL(R) CONSTA(R), the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.
In a study of people taking RISPERDAL CONSTA, the most common side effects in the treatment of Bipolar I Disorder were weight gain (when used alone) and tremors (when used with other medications).
If you have any questions about RISPERDAL(R) CONSTA(R) or your therapy, talk with your doctor.
IMPORTANT SAFETY INFORMATION FOR PROFESSIONALS ABOUT RISPERDAL(R) CONSTA(R)
WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking oral risperidone in clinical trials. The incidence of CAEs with risperidone was significantly higher than with placebo. RISPERDAL(R) CONSTA(R) is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including RISPERDAL(R) CONSTA(R). Clinical manifestations include muscle rigidity, fever, altered mental status and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.
Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL(R) CONSTA(R). Patients starting treatment with APS who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.
Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, RISPERDAL(R) CONSTA(R) elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.
Orthostatic Hypotension: RISPERDAL(R) CONSTA(R) may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. RISPERDAL(R) CONSTA(R) should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.
Potential for Cognitive and Motor Impairment: RISPERDAL(R) CONSTA(R) has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL(R) CONSTA(R) does not affect them adversely.
Seizures: RISPERDAL(R) CONSTA(R) should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold.
Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.
Priapism has been reported. Severe priapism may require surgical intervention.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported.
Administration: Care should be taken to avoid inadvertent injection into a blood vessel.
Suicide: The possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy.
Increased sensitivity in patients with Parkinson's disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.
Use Risperdal Consta with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses. (e.g. Recent Myocardial infarction or unstable cardiac disease)
Extrapyramidal Symptoms (EPS): The overall incidence of EPS-related adverse events in patients treated with 25 mg and 50 mg of RISPERDAL(R) CONSTA(R) and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%, 9%) and tremor (0%, 3%, 0%).
-- Akathisia and restlessness
-- Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia
Weight Gain: In a 12-week trial, the percentage of patients experiencing weight gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL(R) CONSTA(R).
Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment.
Commonly Observed Adverse Reactions for RISPERDAL(R) CONSTA(R): The most common adverse reactions in clinical trials in patients with schizophrenia (greater than or equal to 5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth.
The most common adverse reactions in clinical trials in patients with bipolar disorder trials were weight increase (5% in monotherapy trial) and tremor and parkinsonism (greater than or equal to 10% in adjunctive therapy trial).
Bipolar Disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression). Type I Bipolar Disorder is characterized based on the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the American adult population in any given year.
A randomized, double-blind, placebo-controlled, long-term study was conducted to evaluate the effect of RISPERDAL(R) CONSTA(R) as maintenance therapy in patients who met DSM-IV criteria for Bipolar I Disorder who were stable on medications or experiencing an acute manic or mixed episode. In the first phase of the study, 303 patients were stabilized on open-label RISPERDAL(R) CONSTA(R) for 26 weeks. In the double-blind phase, patients were randomized to either maintenance therapy with RISPERDAL(R) CONSTA(R) (N=154) or placebo (N=149). The median duration of treatment was nine months for patients in the RISPERDAL(R) CONSTA(R) group and five months for patients in the placebo group. The primary endpoint was time to relapse of any mood episode (depression, mania, or mixed).
Time to relapse was significantly longer in patients receiving RISPERDAL(R) CONSTA(R) monotherapy as compared to placebo (p
RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment (RLAT) is a long-acting injectable atypical antipsychotic therapy used for the treatment of schizophrenia and the maintenance treatment of Bipolar I Disorder. It was developed utilizing Alkermes' proprietary Medisorb(R) drug-delivery technology. Using this technology, risperidone is encapsulated in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and administered to patients by intramuscular injection once every two weeks. RISPERDAL(R) CONSTA(R) is manufactured by Alkermes, Inc. and marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and Janssen-Cilag outside of the U.S.
About Janssen
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. It currently has prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder.
About J&JPRD
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide.
IMPORTANT SAFETY INFORMATION FOR CONSUMERS ABOUT RISPERDAL(R) CONSTA(R)
Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL(R) CONSTA(R) and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL(R) CONSTA(R) and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
High blood sugar and diabetes have been reported with RISPERDAL(R) CONSTA(R) and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with RISPERDAL(R) CONSTA(R). Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.
RISPERDAL(R) CONSTA(R) and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.
Some people taking RISPERDAL(R) CONSTA(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 healthcare professional's dosing instructions, this side effect can be reduced or it may go away over time.
Problems with the blood have been reported with RISPERDAL(R) CONSTA(R) and similar medications. Depending upon condition your doctor may choose to monitor your blood as you start therapy with RISPERDAL(R) CONSTA.
RISPERDAL(R) CONSTA(R) may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.
RISPERDAL(R) CONSTA(R) should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Painful, long lasting erections have been reported with the use of RISPERDAL(R) CONSTA(R). Call your doctor immediately if you think you are having this problem.
Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.
Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL(R) CONSTA(R). Caution should be exercised when administering RISPERDAL(R) CONSTA(R) to a nursing woman.
RISPERDAL(R) CONSTA(R) may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.
Some medications interact with RISPERDAL(R) CONSTA(R). Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL(R) CONSTA(R).
In a study of people taking RISPERDAL(R) CONSTA(R), the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.
In a study of people taking RISPERDAL CONSTA, the most common side effects in the treatment of Bipolar I Disorder were weight gain (when used alone) and tremors (when used with other medications).
If you have any questions about RISPERDAL(R) CONSTA(R) or your therapy, talk with your doctor.
IMPORTANT SAFETY INFORMATION FOR PROFESSIONALS ABOUT RISPERDAL(R) CONSTA(R)
WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking oral risperidone in clinical trials. The incidence of CAEs with risperidone was significantly higher than with placebo. RISPERDAL(R) CONSTA(R) is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including RISPERDAL(R) CONSTA(R). Clinical manifestations include muscle rigidity, fever, altered mental status and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.
Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL(R) CONSTA(R). Patients starting treatment with APS who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.
Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, RISPERDAL(R) CONSTA(R) elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.
Orthostatic Hypotension: RISPERDAL(R) CONSTA(R) may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. RISPERDAL(R) CONSTA(R) should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.
Potential for Cognitive and Motor Impairment: RISPERDAL(R) CONSTA(R) has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL(R) CONSTA(R) does not affect them adversely.
Seizures: RISPERDAL(R) CONSTA(R) should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold.
Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.
Priapism has been reported. Severe priapism may require surgical intervention.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported.
Administration: Care should be taken to avoid inadvertent injection into a blood vessel.
Suicide: The possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy.
Increased sensitivity in patients with Parkinson's disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.
Use Risperdal Consta with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses. (e.g. Recent Myocardial infarction or unstable cardiac disease)
Extrapyramidal Symptoms (EPS): The overall incidence of EPS-related adverse events in patients treated with 25 mg and 50 mg of RISPERDAL(R) CONSTA(R) and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%, 9%) and tremor (0%, 3%, 0%).
-- Akathisia and restlessness
-- Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia
Weight Gain: In a 12-week trial, the percentage of patients experiencing weight gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL(R) CONSTA(R).
Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment.
Commonly Observed Adverse Reactions for RISPERDAL(R) CONSTA(R): The most common adverse reactions in clinical trials in patients with schizophrenia (greater than or equal to 5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth.
The most common adverse reactions in clinical trials in patients with bipolar disorder trials were weight increase (5% in monotherapy trial) and tremor and parkinsonism (greater than or equal to 10% in adjunctive therapy trial).
воскресенье, 17 апреля 2011 г.
Course Of Bipolar Disorder In Youths Described For The First Time
Children with bipolar disorder experience more enduring and rapidly changing symptoms of the disease than adults, according to a study that, for the first time, maps the clinical progression of each of the three sub-types of bipolar disorder in children and adolescents. The findings were published today by researchers from the University of Pittsburgh School of Medicine in the February issue of Archives of General Psychiatry. An estimated one out of 100 children and teenagers worldwide has bipolar disorder.
"Bipolar disorder is a serious illness that often emerges in adolescence, yet the majority of research into the disease has been done in adults. It became clear that we needed to define how bipolar disorder presents itself in this young, vulnerable population so we could take the next step of developing more age-specific treatments and therapies," said Boris Birmaher, M.D., professor of psychiatry at the University of Pittsburgh School of Medicine, and principal investigator and lead author of the study. "We found that the symptoms of bipolar disorder were longer lasting and more variable in youths than in adults. To have such symptoms at a young age deprives these children of the opportunity to experience normal emotional, cognitive and social development, establishing the urgent need to diagnose and treat these patients early on."
The study assessed the symptoms of 263 children and adolescents between the ages of 7 and 17 years who were diagnosed with bipolar spectrum disorders. Bipolar disorder, commonly called manic-depressive illness, is characterized by swings between depression, mania and periods with mixed symptoms. Bipolar spectrum disorders consist of three sub-types. Bipolar I (BP-I) is characterized by episodes of full-blown mania and major depression; bipolar II (BP-II) involves episodes of less severe mania, called hypomania, and major depression. The third sub-type, called bipolar not otherwise specified (BP-NOS), was defined in this study as having symptoms consistent with elated or irritable moods that are disruptive to daily living, plus two to three other symptoms of bipolar disorder, such as changes in sleep and appetite, difficulty with concentration or inappropriate social behavior.
Participants were interviewed on average every 35 weeks over a time period of approximately two years. Their symptoms, family history and socio-economic status were evaluated using a host of well-accepted clinical evaluation tools.
Researchers found that participants were symptomatic with either manic or depressive moods 60 percent of the time. While two-thirds of the participants recovered from their initial episode, half had at least one full recurrence of a manic or depressive episode. Participants with BP-I and BP-II experienced faster recovery, but also experienced a shorter time to recurrence, while the BP-NOS group had more protracted illness. Those with BP-I had more manic and mixed episodes, consisting of both mania and depression, than those with BP-NOS, and those with BP-II had more depression than those with BP-I and BP-NOS. Those with BP-NOS were more likely to display symptoms of bipolar disorder that were not severe enough to warrant a diagnosis of a manic or depressive episode.
In comparison to adults with bipolar disorder, researchers found that children and adolescents experienced faster cycling between symptomatic periods. Adults may go months to years between cycles, where as in children, the researchers found the lapse of time to be a matter of weeks.
Interestingly, over the course of the study participants showed numerous and significant changes in their symptoms, often leading to changes in diagnoses. Twenty percent of the participants with BP-II converted to BP-I and 25 percent of the BP-NOS group transitioned to a diagnosis of BP-I or BP-II.
The Course and Outcome of Bipolar Illness in Youths (COBY) study is a collaborative National Institute of Mental Health-funded study being conducted by the University of Pittsburgh, Brown University and the University of California at Los Angeles. It is the largest study of pediatric patients with bipolar disorder to date, and the first prospective naturalistic study of children and adolescents with bipolar spectrum disorders.
"Bipolar disorder is a serious illness that often emerges in adolescence, yet the majority of research into the disease has been done in adults. It became clear that we needed to define how bipolar disorder presents itself in this young, vulnerable population so we could take the next step of developing more age-specific treatments and therapies," said Boris Birmaher, M.D., professor of psychiatry at the University of Pittsburgh School of Medicine, and principal investigator and lead author of the study. "We found that the symptoms of bipolar disorder were longer lasting and more variable in youths than in adults. To have such symptoms at a young age deprives these children of the opportunity to experience normal emotional, cognitive and social development, establishing the urgent need to diagnose and treat these patients early on."
The study assessed the symptoms of 263 children and adolescents between the ages of 7 and 17 years who were diagnosed with bipolar spectrum disorders. Bipolar disorder, commonly called manic-depressive illness, is characterized by swings between depression, mania and periods with mixed symptoms. Bipolar spectrum disorders consist of three sub-types. Bipolar I (BP-I) is characterized by episodes of full-blown mania and major depression; bipolar II (BP-II) involves episodes of less severe mania, called hypomania, and major depression. The third sub-type, called bipolar not otherwise specified (BP-NOS), was defined in this study as having symptoms consistent with elated or irritable moods that are disruptive to daily living, plus two to three other symptoms of bipolar disorder, such as changes in sleep and appetite, difficulty with concentration or inappropriate social behavior.
Participants were interviewed on average every 35 weeks over a time period of approximately two years. Their symptoms, family history and socio-economic status were evaluated using a host of well-accepted clinical evaluation tools.
Researchers found that participants were symptomatic with either manic or depressive moods 60 percent of the time. While two-thirds of the participants recovered from their initial episode, half had at least one full recurrence of a manic or depressive episode. Participants with BP-I and BP-II experienced faster recovery, but also experienced a shorter time to recurrence, while the BP-NOS group had more protracted illness. Those with BP-I had more manic and mixed episodes, consisting of both mania and depression, than those with BP-NOS, and those with BP-II had more depression than those with BP-I and BP-NOS. Those with BP-NOS were more likely to display symptoms of bipolar disorder that were not severe enough to warrant a diagnosis of a manic or depressive episode.
In comparison to adults with bipolar disorder, researchers found that children and adolescents experienced faster cycling between symptomatic periods. Adults may go months to years between cycles, where as in children, the researchers found the lapse of time to be a matter of weeks.
Interestingly, over the course of the study participants showed numerous and significant changes in their symptoms, often leading to changes in diagnoses. Twenty percent of the participants with BP-II converted to BP-I and 25 percent of the BP-NOS group transitioned to a diagnosis of BP-I or BP-II.
The Course and Outcome of Bipolar Illness in Youths (COBY) study is a collaborative National Institute of Mental Health-funded study being conducted by the University of Pittsburgh, Brown University and the University of California at Los Angeles. It is the largest study of pediatric patients with bipolar disorder to date, and the first prospective naturalistic study of children and adolescents with bipolar spectrum disorders.
суббота, 16 апреля 2011 г.
Men Suffer From Compulsive Shopping Too
Compulsive buying is not just a problem that some women have - it seems that men are just as likely to suffer from it, say researchers from Stanford University, USA. About 5% of adults in the USA say they cannot refrain from shopping for stuff they probably don't want or need.
The traditional view of women suffering from compulsive buying is probably the result of most studies being done mainly on women. Women are also more likely to admit to compulsive shopping than men.
You can read about this new study in the American Journal of Psychiatry.
Surprisingly, more people from lower incomes suffer from compulsive shopping than people from higher incomes.
Compulsive shoppers enjoy the buzz of shopping and browsing for the things - they experience a 'high' from it. This is followed by distress and remorse when the person realizes that money was spent on things that would never be used.
In this study, 2,500 adults were surveyed by telephone. The researchers determined each person's level of compulsive buying by using a screening device called 'The Compulsive Buying Scale'.
The researchers found that:
-- 5.8% of people are Compulsive buyers
-- 6% of women are Compulsive buyers
-- 5.5% of men are Compulsive buyers
-- A higher percentage of younger people are Compulsive buyers than older people
-- A higher percentage of people who earn less than
-- $50,000 per year are compulsive buyers
-- Male compulsive buyers tend to buy CDs, books, tools, gadgets, computer stuff and cameras.
-- Female compulsive buyers tend to buy clothes, make-up, articles for the home and jewelry.
-- Male compulsive shoppers are more likely to become addicted to auctions than female compulsive shoppers
-- Compulsive buying does not make the sufferer feel any happier
-- Many sufferers experience serious debt, remorse and shame
-- It is not uncommon for the sufferer to hide his/her addiction from family and friends
-- Compulsive buying is as prevalent as many other mental disorders
Is Compulsive Buying a Real Disorder, and Is It Really Compulsive?
Eric Hollander, M.D. and Andrea Allen, Ph.D.
American Journal of Psychiatry 163:1670-1672, October 2006 - doi: 10.1176/appi.ajp.163.10.1670
Click here to see editorial online
Written by:
The traditional view of women suffering from compulsive buying is probably the result of most studies being done mainly on women. Women are also more likely to admit to compulsive shopping than men.
You can read about this new study in the American Journal of Psychiatry.
Surprisingly, more people from lower incomes suffer from compulsive shopping than people from higher incomes.
Compulsive shoppers enjoy the buzz of shopping and browsing for the things - they experience a 'high' from it. This is followed by distress and remorse when the person realizes that money was spent on things that would never be used.
In this study, 2,500 adults were surveyed by telephone. The researchers determined each person's level of compulsive buying by using a screening device called 'The Compulsive Buying Scale'.
The researchers found that:
-- 5.8% of people are Compulsive buyers
-- 6% of women are Compulsive buyers
-- 5.5% of men are Compulsive buyers
-- A higher percentage of younger people are Compulsive buyers than older people
-- A higher percentage of people who earn less than
-- $50,000 per year are compulsive buyers
-- Male compulsive buyers tend to buy CDs, books, tools, gadgets, computer stuff and cameras.
-- Female compulsive buyers tend to buy clothes, make-up, articles for the home and jewelry.
-- Male compulsive shoppers are more likely to become addicted to auctions than female compulsive shoppers
-- Compulsive buying does not make the sufferer feel any happier
-- Many sufferers experience serious debt, remorse and shame
-- It is not uncommon for the sufferer to hide his/her addiction from family and friends
-- Compulsive buying is as prevalent as many other mental disorders
Is Compulsive Buying a Real Disorder, and Is It Really Compulsive?
Eric Hollander, M.D. and Andrea Allen, Ph.D.
American Journal of Psychiatry 163:1670-1672, October 2006 - doi: 10.1176/appi.ajp.163.10.1670
Click here to see editorial online
Written by:
Seroquel XL (Quetiapine Prolonged Release): A Once Daily Formulation For Bipolar Mania And Schizophrenia Launches Today, UK
Today, Seroquel XL (quetiapine prolonged release), a new once daily formulation for schizophrenia and manic episodes associated with bipolar disorder, has become available in the UK.1
AstraZeneca has developed the new formulation of its atypical antipsychotic treatment to meet the needs of patients for whom a once daily dose is preferred and/or for whom1 effective control of symptoms is important. The launch of Seroquel XL is also expected to be welcomed by clinicians as it allows them to titrate to the target daily dose of 600mg by day two.1,2
A recent survey found that 86% of psychiatrists believe that if patient's symptoms are controlled quickly, they are more likely to make a recovery. The survey, conducted by ICM, also confirms that 52% of psychiatrists believe that current treatment options are not sufficient and most of their patients make a compromise on their quality of life due to the resulting symptoms.3
"The launch of Seroquel XL is excellent news for patients and healthcare professionals. Seroquel has shown efficacy across a wide spectrum of symptoms of schizophrenia and bipolar mania and I believe that the new formulation gives an additional option to clinicians wishing to use quetiapine but preferring titration to target dose by day two and a simplified dosing regimen." 2,4,5,6 Dr Allan Young, Director of the University British Colombia Institute of Mental Health
Seroquel XL may also help clinicians meet targets set out in the 10 year programme for improving mental health services (the National Service Framework in Mental Health) and the NHS Plan, which call for more effective and earlier treatments for mental health patients by providing another treatment option.7
Schizophrenia and bipolar disorder are relatively common mental disorders, each affecting approximately one in every 100 people in the UK at some time in their life.8,9 The direct cost to the NHS for treatment of schizophrenia in England and Wales is over ВЈ1 billion per year.10 For bipolar disorder, the cost to the NHS is approximately ВЈ199 million a year.10
The Seroquel SmPC is available on request or can be found at emc.medicines.uk/
Seroquel XL (quetiapine prolonged release) received a licence for treatment of schizophrenia and manic episodes, associated with bipolar disorder in September 2008.1 Seroquel XL is available in the following dosing strengths 50mg, 200mg, 300mg and 400mg. The recommended therapeutic dosing is to start on day one at 300mg and then titrate to 600mg on day two. The dose should be adjusted within the effective dose range of 400mg and 800mg as per day depending on clinical response. In schizophrenia doses over 600mg must be initiated by a specialist.1
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: astrazeneca
References
1. Seroquel XL SmPC, electronic Medicines Compendium, September 2008. emc.medicines.uk (Accessed September 2008)
2. Cutler A, et al. Effectiveness of Extended Release Formulation of Quetiapine as Montherapy for the Treatment of Acute Bipolar Mania (trial D144CC00004). Presented at the Eighth International Review of Bipolar Disorder Conference, Copenhagen, Denmark, 14-16 April, 2008
3. ICM. Psychiatrists Survey conduced amongst 100 UK Psychiatrists on behalf of AstraZeneca UK. June 2008
4. Small JG, Kolar MC, Kellams JJ. Quetiapine in schizophrenia: onset of action within the first week of treatment. Current Medical Research and Opinion 2004;20:1017-1023
5. Buckley PF. Efficacy of quetiapine for the treatment of schizophrenia: a combined analysis of three placebo-controlled trials. Curr Med Res Opin. 2004;20:1357-1363
6. Vieta E et al. Quetiapine monotherapy for mania associated with bipolar disorder; combined analyses of two international, double blind, randomised, placebo-controlled studies. Curr Med Res Opin. 2005 Jun;21(6):923-934
7. National Service Frameworks. A National Service Framework for Mental Health Modern Standards & Service Models. 1999. (Accessed September 2008)
8. Rethink. Schizophrenia factsheet (RET10113). (Accessed September 2008)
9. Bipolar Disorder. Rethink (Accessed 2008)
10. Mind. Statistics 5: The financial aspects of mental health problems _ (Accessed September 2008)
astrazeneca
View drug information on Seroquel.
AstraZeneca has developed the new formulation of its atypical antipsychotic treatment to meet the needs of patients for whom a once daily dose is preferred and/or for whom1 effective control of symptoms is important. The launch of Seroquel XL is also expected to be welcomed by clinicians as it allows them to titrate to the target daily dose of 600mg by day two.1,2
A recent survey found that 86% of psychiatrists believe that if patient's symptoms are controlled quickly, they are more likely to make a recovery. The survey, conducted by ICM, also confirms that 52% of psychiatrists believe that current treatment options are not sufficient and most of their patients make a compromise on their quality of life due to the resulting symptoms.3
"The launch of Seroquel XL is excellent news for patients and healthcare professionals. Seroquel has shown efficacy across a wide spectrum of symptoms of schizophrenia and bipolar mania and I believe that the new formulation gives an additional option to clinicians wishing to use quetiapine but preferring titration to target dose by day two and a simplified dosing regimen." 2,4,5,6 Dr Allan Young, Director of the University British Colombia Institute of Mental Health
Seroquel XL may also help clinicians meet targets set out in the 10 year programme for improving mental health services (the National Service Framework in Mental Health) and the NHS Plan, which call for more effective and earlier treatments for mental health patients by providing another treatment option.7
Schizophrenia and bipolar disorder are relatively common mental disorders, each affecting approximately one in every 100 people in the UK at some time in their life.8,9 The direct cost to the NHS for treatment of schizophrenia in England and Wales is over ВЈ1 billion per year.10 For bipolar disorder, the cost to the NHS is approximately ВЈ199 million a year.10
The Seroquel SmPC is available on request or can be found at emc.medicines.uk/
Seroquel XL (quetiapine prolonged release) received a licence for treatment of schizophrenia and manic episodes, associated with bipolar disorder in September 2008.1 Seroquel XL is available in the following dosing strengths 50mg, 200mg, 300mg and 400mg. The recommended therapeutic dosing is to start on day one at 300mg and then titrate to 600mg on day two. The dose should be adjusted within the effective dose range of 400mg and 800mg as per day depending on clinical response. In schizophrenia doses over 600mg must be initiated by a specialist.1
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: astrazeneca
References
1. Seroquel XL SmPC, electronic Medicines Compendium, September 2008. emc.medicines.uk (Accessed September 2008)
2. Cutler A, et al. Effectiveness of Extended Release Formulation of Quetiapine as Montherapy for the Treatment of Acute Bipolar Mania (trial D144CC00004). Presented at the Eighth International Review of Bipolar Disorder Conference, Copenhagen, Denmark, 14-16 April, 2008
3. ICM. Psychiatrists Survey conduced amongst 100 UK Psychiatrists on behalf of AstraZeneca UK. June 2008
4. Small JG, Kolar MC, Kellams JJ. Quetiapine in schizophrenia: onset of action within the first week of treatment. Current Medical Research and Opinion 2004;20:1017-1023
5. Buckley PF. Efficacy of quetiapine for the treatment of schizophrenia: a combined analysis of three placebo-controlled trials. Curr Med Res Opin. 2004;20:1357-1363
6. Vieta E et al. Quetiapine monotherapy for mania associated with bipolar disorder; combined analyses of two international, double blind, randomised, placebo-controlled studies. Curr Med Res Opin. 2005 Jun;21(6):923-934
7. National Service Frameworks. A National Service Framework for Mental Health Modern Standards & Service Models. 1999. (Accessed September 2008)
8. Rethink. Schizophrenia factsheet (RET10113). (Accessed September 2008)
9. Bipolar Disorder. Rethink (Accessed 2008)
10. Mind. Statistics 5: The financial aspects of mental health problems _ (Accessed September 2008)
astrazeneca
View drug information on Seroquel.
Seroquel: New Data Shows Efficacy in Bipolar Depression from Week 1
New data presented today at the American Psychiatric Association Annual
Meeting show that Seroquel (quetiapine) 600mg/day significantly improves
depression ratings* including a significant reduction in suicidal thoughts
as early as Week 11. The findings also demonstrated that Seroquel improved
quality of life2 and adherence to treatment3.
Seroquel is not licensed for bipolar depression. Seroquel is currently
licensed for the treatment of manic episodes associated with bipolar
disorder and for the treatment of schizophrenia.4
The BOLDER (BipOLar DepRession) study is an eight-week, multi-centered,
randomised, double-blind, placebo-controlled study involving 542 patients
with a diagnosis of bipolar I or bipolar II disorder. Seroquel demonstrated
efficacy in the treatment of bipolar depression, significantly improving
core symptoms of depression1 (symptoms include apparent sadness, inability
to feel and suicidal thoughts). The trial found that 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
groups2.
"Suicidal thoughts are a common symptom of bipolar disorder and
astonishingly 25% to 50% of people with untreated or inadequately treated
bipolar disorder attempt suicide", commented Professor Allan Young,
Professor of Psychiatry, Royal Victoria Hospital, Newcastle. "These
findings are highly relevant to patient care as this is the first time we
have seen this level of efficacy in reducing suicidal thinking with an
atypical antipsychotic in bipolar disorder. The results show that those
treated with Seroquel benefit from a strong efficacy profile, combined with
improved compliance and quality of life. The fact that Seroquel is
effective in reducing suicidal thoughts within just 1 week and is well
tolerated over 8 weeks, should inform clinicians looking to treat their
patients both in the here and now and for the future."
Bipolar I disorder is a severe mood disorder where patients swing between
states of depression (low mood and energy) and mania (heightened, elevated,
ecstatic mood and energy). Bipolar II disorder is a variant whereby patients
swing between intense depression and a milder manic state known as
'hypomania'. Patients with both types of bipolar disorder spend
significantly longer depressed than manic or hypomanic6, and yet
historically the treatment of the depressive phase has not been well
studied.7
"There is a major unmet need for effective options for healthcare
professionals treating bipolar depression" commented Michelle Rowett, Chief
Executive, MDF The Bipolar Organisation. "Antidepressants normally take a
number of weeks before they have any effect, and there is also a risk that
they may trigger a manic episode. We welcome research into new treatments
for bipolar depression, and this data indicates that quetiapine may be a
useful addition to treatment options for bipolar depression."
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the
world's leading pharmaceutical companies with healthcare sales of over $21.4
billion and leading positions in sales of gastrointestinal, cardiovascular,
respiratory, oncology and neuroscience products. AstraZeneca is listed in
the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.
In Neuroscience, AstraZeneca is dedicated to providing medicines that have
the potential to change patients' lives. The company already markets several
products including Seroquel, one of the fastest growing global
antipsychotics with proven efficacy and a very favourable side effect
profile; and Zomig, a reliable migraine therapy and a leader within the
triptan market. The Neuroscience pipeline includes leading approaches for
the treatment of depression and anxiety, overactive bladder, dementia and
stroke, pain control and anaesthesia.
* As measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and
the Hamilton Rating Scale for Anxiety (HAM-A)
** The Quality of Life Satisfaction Scale Questionnaire (Q-LES-Q)
Seroquel is a trademark of the AstraZeneca group of companies.
Seroquel has been licensed for the treatment of schizophrenia since 1997 and
is available in 82 countries for the treatment of this condition. SEROQUEL
is also licensed in 63 countries for the treatment of mania associated with
bipolar disorder, including the US, Canada and several European countries.
To date, over 8 million people have been treated with SEROQUEL worldwide.
Results:
Reducing suicidal thinking key to reducing high suicide rates1:
(As measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and
the Hamilton Rating Scale for Anxiety (HAM-A))
These data, from the BOLDER (BipOLar DEpRession) trial, an eight week,
multi-centered, 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
Meeting show that Seroquel (quetiapine) 600mg/day significantly improves
depression ratings* including a significant reduction in suicidal thoughts
as early as Week 11. The findings also demonstrated that Seroquel improved
quality of life2 and adherence to treatment3.
Seroquel is not licensed for bipolar depression. Seroquel is currently
licensed for the treatment of manic episodes associated with bipolar
disorder and for the treatment of schizophrenia.4
The BOLDER (BipOLar DepRession) study is an eight-week, multi-centered,
randomised, double-blind, placebo-controlled study involving 542 patients
with a diagnosis of bipolar I or bipolar II disorder. Seroquel demonstrated
efficacy in the treatment of bipolar depression, significantly improving
core symptoms of depression1 (symptoms include apparent sadness, inability
to feel and suicidal thoughts). The trial found that 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
groups2.
"Suicidal thoughts are a common symptom of bipolar disorder and
astonishingly 25% to 50% of people with untreated or inadequately treated
bipolar disorder attempt suicide", commented Professor Allan Young,
Professor of Psychiatry, Royal Victoria Hospital, Newcastle. "These
findings are highly relevant to patient care as this is the first time we
have seen this level of efficacy in reducing suicidal thinking with an
atypical antipsychotic in bipolar disorder. The results show that those
treated with Seroquel benefit from a strong efficacy profile, combined with
improved compliance and quality of life. The fact that Seroquel is
effective in reducing suicidal thoughts within just 1 week and is well
tolerated over 8 weeks, should inform clinicians looking to treat their
patients both in the here and now and for the future."
Bipolar I disorder is a severe mood disorder where patients swing between
states of depression (low mood and energy) and mania (heightened, elevated,
ecstatic mood and energy). Bipolar II disorder is a variant whereby patients
swing between intense depression and a milder manic state known as
'hypomania'. Patients with both types of bipolar disorder spend
significantly longer depressed than manic or hypomanic6, and yet
historically the treatment of the depressive phase has not been well
studied.7
"There is a major unmet need for effective options for healthcare
professionals treating bipolar depression" commented Michelle Rowett, Chief
Executive, MDF The Bipolar Organisation. "Antidepressants normally take a
number of weeks before they have any effect, and there is also a risk that
they may trigger a manic episode. We welcome research into new treatments
for bipolar depression, and this data indicates that quetiapine may be a
useful addition to treatment options for bipolar depression."
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the
world's leading pharmaceutical companies with healthcare sales of over $21.4
billion and leading positions in sales of gastrointestinal, cardiovascular,
respiratory, oncology and neuroscience products. AstraZeneca is listed in
the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.
In Neuroscience, AstraZeneca is dedicated to providing medicines that have
the potential to change patients' lives. The company already markets several
products including Seroquel, one of the fastest growing global
antipsychotics with proven efficacy and a very favourable side effect
profile; and Zomig, a reliable migraine therapy and a leader within the
triptan market. The Neuroscience pipeline includes leading approaches for
the treatment of depression and anxiety, overactive bladder, dementia and
stroke, pain control and anaesthesia.
* As measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and
the Hamilton Rating Scale for Anxiety (HAM-A)
** The Quality of Life Satisfaction Scale Questionnaire (Q-LES-Q)
Seroquel is a trademark of the AstraZeneca group of companies.
Seroquel has been licensed for the treatment of schizophrenia since 1997 and
is available in 82 countries for the treatment of this condition. SEROQUEL
is also licensed in 63 countries for the treatment of mania associated with
bipolar disorder, including the US, Canada and several European countries.
To date, over 8 million people have been treated with SEROQUEL worldwide.
Results:
Reducing suicidal thinking key to reducing high suicide rates1:
(As measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and
the Hamilton Rating Scale for Anxiety (HAM-A))
These data, from the BOLDER (BipOLar DEpRession) trial, an eight week,
multi-centered, 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
Bipolar Disorder Does Not Increase Risk Of Violent Crime
A new study from Sweden's Karolinska Institutet suggests that bipolar disorder - or manic-depressive disorder - does not increase the risk of committing violent crime. Instead, the over-representation of individuals with bipolar disorder in violent crime statistics is almost entirely attributable to concurrent substance abuse.
The public debate on violent crime usually assumes that violence in the mentally ill is a direct result of the perpetrator's illness. Previous research has also suggested that patients with bipolar disorder - also known as manic-depressive disorder - are more likely to behave violently. However, it has been unclear if the violence is due to the bipolar disorder per se, or caused by other aspects of the individual's personality or lifestyle.
The new study, carried out by researchers at Karolinska Institutet and Oxford University, is presented in the scientific journal Archives of General Psychiatry. Researchers compared the rate of violent crime in over 3,700 patients with bipolar disorder cared for in Swedish hospitals between 1973 and 2004 with that of 37,000 control individuals from the general public.
21% of patients with bipolar disorder and a concurrent diagnosis of severe substance abuse (alcohol or illegal drugs) were convicted of violent crimes, compared to 5% of those with bipolar disorder but without substance abuse, and 3% among general public control individuals. The differences remained when accounting for age, gender, immigrant background, socio-economic status, and whether the most recent presentation of the bipolar disorder was manic or depressed.
"Interestingly, this concurs with our group's previous findings in schizophrenia, another serious psychiatric disorder, which found that individuals with schizophrenia are not more violent than members of the general public, provided there is no substance abuse," says professor Niklas Långström, head of the Centre for Violence Prevention at Karolinska Institutet, and one of the researchers behind the study.
According to the researchers, the findings support the need for initiatives to prevent, identify and treat substance abuse when fighting violent crime. Additionally, Långström hopes that the results will help challenge overly simplistic explanations of the causes of violent crime.
"Unwarranted fear and stigmatisation of mental illness increases the alienation of people with psychiatric disorder and makes them less inclined to seek the care they need", Långström comments.
Publication:
Seena Fazel, Paul Lichtenstein, Martin Grann, Guy M. Goodwin, Niklas Långström
Bipolar disorder and violent crime: new evidence from population-based longitudinal studies and systematic review
Archives of General Psychiatry, online 6 September 2010
Source:
Katarina Sternudd
Karolinska Institutet
The public debate on violent crime usually assumes that violence in the mentally ill is a direct result of the perpetrator's illness. Previous research has also suggested that patients with bipolar disorder - also known as manic-depressive disorder - are more likely to behave violently. However, it has been unclear if the violence is due to the bipolar disorder per se, or caused by other aspects of the individual's personality or lifestyle.
The new study, carried out by researchers at Karolinska Institutet and Oxford University, is presented in the scientific journal Archives of General Psychiatry. Researchers compared the rate of violent crime in over 3,700 patients with bipolar disorder cared for in Swedish hospitals between 1973 and 2004 with that of 37,000 control individuals from the general public.
21% of patients with bipolar disorder and a concurrent diagnosis of severe substance abuse (alcohol or illegal drugs) were convicted of violent crimes, compared to 5% of those with bipolar disorder but without substance abuse, and 3% among general public control individuals. The differences remained when accounting for age, gender, immigrant background, socio-economic status, and whether the most recent presentation of the bipolar disorder was manic or depressed.
"Interestingly, this concurs with our group's previous findings in schizophrenia, another serious psychiatric disorder, which found that individuals with schizophrenia are not more violent than members of the general public, provided there is no substance abuse," says professor Niklas Långström, head of the Centre for Violence Prevention at Karolinska Institutet, and one of the researchers behind the study.
According to the researchers, the findings support the need for initiatives to prevent, identify and treat substance abuse when fighting violent crime. Additionally, Långström hopes that the results will help challenge overly simplistic explanations of the causes of violent crime.
"Unwarranted fear and stigmatisation of mental illness increases the alienation of people with psychiatric disorder and makes them less inclined to seek the care they need", Långström comments.
Publication:
Seena Fazel, Paul Lichtenstein, Martin Grann, Guy M. Goodwin, Niklas Långström
Bipolar disorder and violent crime: new evidence from population-based longitudinal studies and systematic review
Archives of General Psychiatry, online 6 September 2010
Source:
Katarina Sternudd
Karolinska Institutet
If Bipolar Disorder Is Over-Diagnosed, What Are The Actual Diagnoses?
A year ago, a study by Rhode Island Hospital and Brown University researchers reported that fewer than half the patients previously diagnosed with bipolar disorder received an actual diagnosis of bipolar disorder after using a comprehensive, psychiatric diagnostic interview tool -- the Structured Clinical Interview for DSM-IV (SCID). In this follow-up study, the researchers have determined the actual diagnoses of those patients. Their study is published in the July 28 ahead of print online edition of The Journal of Clinical Psychiatry.
Under the direction of lead author Mark Zimmerman, MD, director of outpatient psychiatry at Rhode Island Hospital, the researchers' findings indicate that patients who received a previous diagnosis of bipolar disorder that was not confirmed by a SCID, they were significantly more likely to be diagnosed with borderline personality disorder as well as impulse control disorders.
Their research involved the study of 82 psychiatric outpatients who reported that they received a previous diagnosis of bipolar disorder that was not later confirmed through the use of the SCID. The diagnoses in these patients were compared to 528 patients who were not previously diagnosed with bipolar disorder. The study was conducted between May 2001 and March 2005.
Zimmerman, who is also an associate professor of psychiatry and human behavior at The Warren Alpert Medical School of Brown University, says, "In our study, one quarter of the patients over-diagnosed with bipolar disorder met DSM-IV criteria for borderline personality disorder. Looking at these results another way, nearly 40 percent (20 of 52) of patients diagnosed with DSM-IV borderline personality disorder had been over-diagnosed with bipolar disorder."
The results of the study also indicate that patients who had been over-diagnosed with bipolar disorder were more frequently diagnosed with major depressive disorder, antisocial personality disorder, posttraumatic stress disorder and eating and impulse disorders.
Zimmerman and colleagues note that "we hypothesize that in patients with mood instability, physicians are inclined to diagnose a potentially medication-responsive disorder such as bipolar disorder rather than a disorder such as borderline personality disorder that is less medication-responsive."
In their previously published study that concluded bipolar disorder was over-diagnosed, they studied 700 patients. Of the 700 patients, 145 reported they had been previously diagnosed as having bipolar disorder; however, fewer than half of the 145 patients (43.4 percent) were diagnosed with bipolar disorder based on the SCID. The authors state that the over-diagnosis of bipolar disorder can have serious consequences, because while bipolar disorder is treated with mood stabilizers, no medications have been approved for the treatment of borderline personality disorder. As a result, over-diagnosing bipolar disorder can unnecessarily expose patients to serious medication side effects, including possible impact to renal, endocrine, hepatic, immunologic and metabolic functions.
Zimmerman concludes, "Because evidence continues to emerge establishing the efficacy of certain forms of psychotherapy for borderline personality disorder, over-diagnosing bipolar disorder in patients with borderline personality disorder can result in the failure to recommend the most appropriate forms of treatment."
The report is from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) Project, for which Zimmerman is the principal investigator. Zimmerman said, "The MIDAS project is unique in its integration of research quality diagnostic methods into a community-based outpatient practice affiliated with an academic medical center."
Along with Zimmerman, other researchers involved in the study include Camile Ruggero, PhD; Iwona Chelminski, PhD and Diane Young, PhD, all of Rhode Island Hospital and Brown University.
Founded in 1863, Rhode Island Hospital (rhodeislandhospital) in Providence, RI, is a private, not-for-profit hospital and is the largest teaching hospital of the Warren Alpert Medical School of Brown University. A major trauma center for southeastern New England, the hospital is dedicated to being on the cutting edge of medicine and research. Many of its physicians are recognized as leaders in their respective fields of cancer, cardiology, diabetes, emergency medicine and trauma, neuroscience, orthopedics, pediatrics, radiation oncology and surgery. Rhode Island Hospital receives nearly $50 million each year in external research funding. It is home to Hasbro Children's Hospital, the state's only facility dedicated to pediatric care, which is ranked among the top 30 children's hospitals in the country by Parents magazine. Rhode Island Hospital is a founding member of the Lifespan health system.
Source:
Nancy Cawley Jean
Lifespan
Under the direction of lead author Mark Zimmerman, MD, director of outpatient psychiatry at Rhode Island Hospital, the researchers' findings indicate that patients who received a previous diagnosis of bipolar disorder that was not confirmed by a SCID, they were significantly more likely to be diagnosed with borderline personality disorder as well as impulse control disorders.
Their research involved the study of 82 psychiatric outpatients who reported that they received a previous diagnosis of bipolar disorder that was not later confirmed through the use of the SCID. The diagnoses in these patients were compared to 528 patients who were not previously diagnosed with bipolar disorder. The study was conducted between May 2001 and March 2005.
Zimmerman, who is also an associate professor of psychiatry and human behavior at The Warren Alpert Medical School of Brown University, says, "In our study, one quarter of the patients over-diagnosed with bipolar disorder met DSM-IV criteria for borderline personality disorder. Looking at these results another way, nearly 40 percent (20 of 52) of patients diagnosed with DSM-IV borderline personality disorder had been over-diagnosed with bipolar disorder."
The results of the study also indicate that patients who had been over-diagnosed with bipolar disorder were more frequently diagnosed with major depressive disorder, antisocial personality disorder, posttraumatic stress disorder and eating and impulse disorders.
Zimmerman and colleagues note that "we hypothesize that in patients with mood instability, physicians are inclined to diagnose a potentially medication-responsive disorder such as bipolar disorder rather than a disorder such as borderline personality disorder that is less medication-responsive."
In their previously published study that concluded bipolar disorder was over-diagnosed, they studied 700 patients. Of the 700 patients, 145 reported they had been previously diagnosed as having bipolar disorder; however, fewer than half of the 145 patients (43.4 percent) were diagnosed with bipolar disorder based on the SCID. The authors state that the over-diagnosis of bipolar disorder can have serious consequences, because while bipolar disorder is treated with mood stabilizers, no medications have been approved for the treatment of borderline personality disorder. As a result, over-diagnosing bipolar disorder can unnecessarily expose patients to serious medication side effects, including possible impact to renal, endocrine, hepatic, immunologic and metabolic functions.
Zimmerman concludes, "Because evidence continues to emerge establishing the efficacy of certain forms of psychotherapy for borderline personality disorder, over-diagnosing bipolar disorder in patients with borderline personality disorder can result in the failure to recommend the most appropriate forms of treatment."
The report is from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) Project, for which Zimmerman is the principal investigator. Zimmerman said, "The MIDAS project is unique in its integration of research quality diagnostic methods into a community-based outpatient practice affiliated with an academic medical center."
Along with Zimmerman, other researchers involved in the study include Camile Ruggero, PhD; Iwona Chelminski, PhD and Diane Young, PhD, all of Rhode Island Hospital and Brown University.
Founded in 1863, Rhode Island Hospital (rhodeislandhospital) in Providence, RI, is a private, not-for-profit hospital and is the largest teaching hospital of the Warren Alpert Medical School of Brown University. A major trauma center for southeastern New England, the hospital is dedicated to being on the cutting edge of medicine and research. Many of its physicians are recognized as leaders in their respective fields of cancer, cardiology, diabetes, emergency medicine and trauma, neuroscience, orthopedics, pediatrics, radiation oncology and surgery. Rhode Island Hospital receives nearly $50 million each year in external research funding. It is home to Hasbro Children's Hospital, the state's only facility dedicated to pediatric care, which is ranked among the top 30 children's hospitals in the country by Parents magazine. Rhode Island Hospital is a founding member of the Lifespan health system.
Source:
Nancy Cawley Jean
Lifespan
More Than $3 Million Grant To Develop Therapies For Biological Clock Disorders
The Scripps Research Institute has been awarded $3.17 million over four years to develop compounds that will counteract disruptions of the human biological clock - the circadian rhythm that regulates our patterns of activity and rest over a 24-hour daily cycle. Circadian rhythm disruptions have been associated with sleep disorders, as well as bipolar disease and schizophrenia.
The grant, from the National Institutes of Health (NIH), was awarded to Thomas Burris, a professor in the Department of Molecular Therapeutics at Scripps Florida.
The NIH also selected the Burris lab to receive a one-year award of $580,000 to develop compounds that might act against metabolic diseases such as diabetes and obesity and a one-year award of $243,000 to investigate a method of finding compounds that might lead to new treatments for diseases including cancer, inflammation, and diabetes.
"These grants will help move our research forward," Burris said. "For the four-year grant to study circadian rhythm disorders, we put together a group of four investigators at Scripps Florida - Pat Griffin, Ted Kamenecka, Andrew Butler, and myself - to investigate the widely accepted idea that circadian rhythms are involved in various disorders such as depression and schizophrenia. We have an initial lead that we believe will result in several new and more effective compounds."
Pat Griffin is chair of the Department of Molecular Therapeutics and director of the Translational Research Institute at Scripps Florida; Ted Kamenecka is associate scientific director of Scripps Florida's Translational Research Institute; and Andrew Butler is an associate professor in the Scripps Florida Department of Metabolism and Aging.
The one-year award to develop compounds for metabolic diseases, Burris said, is a seed grant that could grow into a new and much larger five-year grant involving the same group of Scripps Research scientists.
The Role of Nuclear Receptors
The work for all three grants is related to the Burris lab's work on specific "nuclear receptors," which might be modified with small molecules to counteract a number of disorders. The nuclear hormone receptor family is a large a group of protein molecules that recognize and regulate hormones as well as other natural substances in our body. As a result, these receptors control an organism's metabolism by activating gene expression.
Nuclear receptors make tempting drug targets because they can bind directly to DNA and activate genes through specific ligands - molecules that affect receptor behavior - such as the sex hormones, vitamins A and D, and glucocorticoids, which affect the body's response to stress. Nuclear receptors have been implicated in a number of cancers, including prostate, breast, and colon cancers, and other diseases as well, including type 2 diabetes, atherosclerosis, and metabolic syndrome.
Burris's research involves what are known as orphan nuclear receptors called RORs (retinoic acid receptor-related orphan receptors), a subgroup that plays a role in the expression of genes involved in the regulation of carbohydrate and fat metabolism, as well as circadian rhythm.
"The caveat is that since no one has ever developed ROR-related drugs, we don't know what the side effects might be," Burris said. "On the positive side, however, there is compelling evidence that these receptors are associated with these diseases, particularly the circadian rhythm disorders, and we have several compounds that can target these mechanisms and control them. We're on the cutting edge of this research."
In November of last year, Burris published a study in the Journal of Biological Chemistry that identified for the first time a novel mechanism that regulates circadian rhythm. The mechanism involved a specific ROR as well as another member of the nuclear receptor family.
Another Burris study, published around the same time in the journal ACS Chemical Biology, identified a novel compound acting on a pair of nuclear receptors that could provide new and potentially more effective therapeutic approaches to a range of metabolic diseases.
Source:
Mika Ono
Scripps Research Institute
The grant, from the National Institutes of Health (NIH), was awarded to Thomas Burris, a professor in the Department of Molecular Therapeutics at Scripps Florida.
The NIH also selected the Burris lab to receive a one-year award of $580,000 to develop compounds that might act against metabolic diseases such as diabetes and obesity and a one-year award of $243,000 to investigate a method of finding compounds that might lead to new treatments for diseases including cancer, inflammation, and diabetes.
"These grants will help move our research forward," Burris said. "For the four-year grant to study circadian rhythm disorders, we put together a group of four investigators at Scripps Florida - Pat Griffin, Ted Kamenecka, Andrew Butler, and myself - to investigate the widely accepted idea that circadian rhythms are involved in various disorders such as depression and schizophrenia. We have an initial lead that we believe will result in several new and more effective compounds."
Pat Griffin is chair of the Department of Molecular Therapeutics and director of the Translational Research Institute at Scripps Florida; Ted Kamenecka is associate scientific director of Scripps Florida's Translational Research Institute; and Andrew Butler is an associate professor in the Scripps Florida Department of Metabolism and Aging.
The one-year award to develop compounds for metabolic diseases, Burris said, is a seed grant that could grow into a new and much larger five-year grant involving the same group of Scripps Research scientists.
The Role of Nuclear Receptors
The work for all three grants is related to the Burris lab's work on specific "nuclear receptors," which might be modified with small molecules to counteract a number of disorders. The nuclear hormone receptor family is a large a group of protein molecules that recognize and regulate hormones as well as other natural substances in our body. As a result, these receptors control an organism's metabolism by activating gene expression.
Nuclear receptors make tempting drug targets because they can bind directly to DNA and activate genes through specific ligands - molecules that affect receptor behavior - such as the sex hormones, vitamins A and D, and glucocorticoids, which affect the body's response to stress. Nuclear receptors have been implicated in a number of cancers, including prostate, breast, and colon cancers, and other diseases as well, including type 2 diabetes, atherosclerosis, and metabolic syndrome.
Burris's research involves what are known as orphan nuclear receptors called RORs (retinoic acid receptor-related orphan receptors), a subgroup that plays a role in the expression of genes involved in the regulation of carbohydrate and fat metabolism, as well as circadian rhythm.
"The caveat is that since no one has ever developed ROR-related drugs, we don't know what the side effects might be," Burris said. "On the positive side, however, there is compelling evidence that these receptors are associated with these diseases, particularly the circadian rhythm disorders, and we have several compounds that can target these mechanisms and control them. We're on the cutting edge of this research."
In November of last year, Burris published a study in the Journal of Biological Chemistry that identified for the first time a novel mechanism that regulates circadian rhythm. The mechanism involved a specific ROR as well as another member of the nuclear receptor family.
Another Burris study, published around the same time in the journal ACS Chemical Biology, identified a novel compound acting on a pair of nuclear receptors that could provide new and potentially more effective therapeutic approaches to a range of metabolic diseases.
Source:
Mika Ono
Scripps Research Institute
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