понедельник, 20 июня 2011 г.

ABILIFY Approved For Acute Treatment Of Bipolar I Disorder In Patients 10 To 17 Years Old

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) has announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY® (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old). ABILIFY has been approved for the acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004 and March 2005, respectively.



"Pediatric bipolar illness is a serious condition," said Christoph Correll, M.D., Medical Director, Recognition and Prevention Program, The Zucker Hillside Hospital and Assistant Professor of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Glen Oaks, New York. "The availability of an additional treatment option that can help guide decisions in managing Bipolar I Disorder in children and adolescents is welcome news."



The approval is based on results from a four-week, multicenter, randomized, double-blind, placebo-controlled study in pediatric patients (10 to 17 years old) with Bipolar I Disorder that demonstrated efficacy with ABILIFY compared to placebo on the primary efficacy endpoint, mean change from baseline to Week 4 on the Young-Mania Rating Scale (Y-MRS) Total Score.



"We are pleased that the FDA has approved ABILIFY to treat pediatric patients aged 10 to 17 years suffering from Bipolar I Disorder," said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc. "The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population."



"We are committed to developing innovative new medicines to their fullest potential," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "Expanding the clinical use of an important therapy such as ABILIFY gives pediatric patients with Bipolar I Disorder and their caregivers a new treatment option in their fight against this serious disease."



Clinical Trial Design and Findings



These findings are from a four-week, multicenter, randomized, double-blind, placebo-controlled study, which evaluated the efficacy and safety of ABILIFY in 296 pediatric patients (10 to 17 years old) with a DSM-IV diagnosis of Bipolar I Disorder, manic or mixed episodes, with or without psychotic features. Diagnosis was made by a trained child and adolescent psychiatrist and confirmed by a separate diagnostic interview. This study was conducted on an outpatient basis with the possibility of inpatient hospitalization, as needed. This clinical trial was sponsored by Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ) with enrollment at 54 U.S. centers.
















After a screening period of up to four weeks, pediatric patients (10 to 17 years old) who scored greater than or equal to 20 on the Y-MRS* were randomly assigned to receive one of two fixed doses of ABILIFY [10 mg/day (n=98) or 30 mg/day (n=99)] or placebo (n=99). ABILIFY was initiated at a starting dose of 2 mg/day and titrated to the target dose of 10 mg/day or 30 mg/day.



The primary efficacy endpoint was the mean change in the Y-MRS Total Score from baseline to Week 4. Safety evaluations included incidence of adverse reactions, discontinuation due to adverse reactions, laboratory measures and body weight.



For the primary endpoint, both doses of ABILIFY demonstrated statistically significant improvement in symptoms when compared to placebo (p-value less than 0.0001) as measured by the mean change from baseline to endpoint (Week 4) on the Y-MRS Total Score. The efficacy of ABILIFY for the maintenance treatment of Bipolar I Disorder in the pediatric population has not been evaluated.



Approximately 80% of patients completed the four-week study (ABILIFY 10 mg: 86%; ABILIFY 30 mg: 78%; placebo: 77%). There was a low rate of discontinuation due to adverse reactions at Week 4 (ABILIFY: 7%; placebo: 2%).



During the study, the most commonly observed adverse reactions (greater than or equal to 5% in combined ABILIFY groups and at least twice the rate of placebo) associated with ABILIFY were: somnolence (ABILIFY: 23%; placebo: 3%), extrapyramidal disorder (ABILIFY: 20%; placebo: 3%), fatigue (ABILIFY: 11%; placebo: 4%), nausea (ABILIFY: 11%; placebo: 4%), akathisia (ABILIFY: 10%; placebo: 2%), blurred vision (ABILIFY: 8%; placebo: 0%), salivary hypersecretion (ABILIFY: 6%; placebo: 0%) and dizziness (ABILIFY: 5%; placebo: 1%). Four common adverse reactions had a possible dose-response relationship at Week 4: extrapyramidal disorder (ABILIFY 10 mg: 12.2%; ABILIFY 30 mg: 27.3%; placebo: 3.1%), somnolence (ABILIFY 10 mg: 19.4%; ABILIFY 30 mg: 26.3%; placebo: 3.1%), akathisia (ABILIFY 10 mg: 8.2%; ABILIFY 30 mg: 11.1%; placebo: 2.1%) and salivary hypersecretion (ABILIFY 10 mg: 3.1%; ABILIFY 30 mg: 8.1%; placebo: 0%). Children and adolescents might be more sensitive than adults in developing antipsychotic-related adverse events.(1)



In the study, weight gain greater than or equal to 7% change from baseline was seen in 3.2%, 9.4% and 3.3% for the ABILIFY 10 mg, ABILIFY 30 mg and placebo groups, respectively. The mean change from baseline to Week 4 in body weight was 0.6 kilograms (kg) for ABILIFY 10 mg, 0.9 kg for ABILIFY 30 mg and 0.5 kg for placebo.



In this study, ABILIFY demonstrated no clinically important differences on prolactin and the following metabolic parameters: triglyceride, HDL-C, LDL-C and total cholesterol. All treatment groups showed a reduction in mean serum prolactin levels at last visit relative to baseline.







About ABILIFY® (aripiprazole)



The first and only available dopamine partial agonist, ABILIFY is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and pediatric patients (10 to 17 years old). ABILIFY® (aripiprazole) Injection is indicated for the treatment of adults with agitation associated with Bipolar I Disorder, manic or mixed.



Initially approved in November 2002, over 14.9 million prescriptions have been written for ABILIFY in the U.S.(2) through December 2007.



ABILIFY is available by prescription only. ABILIFY Tablets should be taken once daily with or without food and are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths. ABILIFY® DISCMELT(TM) (aripiprazole) Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. In addition, ABILIFY is available in a 1 mg/mL nonrefrigerated Oral Solution and as a single-dose, ready-to-use solution for intramuscular injection 7.5 mg/mL. In adult patients, the recommended ABILIFY® (aripiprazole) Oral target dose is 15 mg/day to 30 mg/day in Bipolar I Disorder. In pediatric patients (10 to 17 years old) with Bipolar I Disorder, the recommended ABILIFY Oral target dose is 10 mg/day (with a starting dose of 2 mg/day which was titrated to 5 mg/day after 2 days and to the target dose of 10 mg/day after 2 additional days). In adult patients with agitation associated with bipolar mania, the ABILIFY Injection initial dose is 9.75 mg/1.3 mL. If ongoing ABILIFY therapy is clinically indicated, oral ABILIFY in a range of 10 mg/day to 30 mg/day should replace ABILIFY Injection as soon as possible. The safety of doses of ABILIFY Oral or ABILIFY Injection above 30 mg/day has not been evaluated in clinical trials.



IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY



INDICATIONS:



* ABILIFY is indicated for acute and maintenance treatment of adults with manic or mixed episodes associated with Bipolar I Disorder with or without psychotic features



* ABILIFY is indicated for acute treatment of pediatric patients (10 to 17 years old) with manic or mixed episodes associated with Bipolar I Disorder with or without psychotic features



* ABILIFY Injection is indicated for the treatment of adults with agitation associated with Bipolar I Disorder, manic or mixed.



IMPORTANT SAFETY INFORMATION:



Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). ABILIFY is not approved for the treatment of patients with dementia-related psychosis (see Boxed WARNING).



Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive ABILIFY or another antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increased risk of suicidality in adults beyond age 24. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised for the need for close observation and communication with the prescriber. ABILIFY is not approved for use in pediatric patients with depression (See Boxed WARNING).



Contraindications: Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urticaria to anaphylaxis.



Cerebrovascular adverse reactions (eg, stroke, transient ischemic attack), including fatalities, have been reported at an increased incidence in clinical trials of elderly patients with dementia-related psychosis treated with ABILIFY



Neuroleptic malignant syndrome (NMS) - As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with ABILIFY. NMS can cause hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status. If signs and symptoms appear, immediate discontinuation is recommended



Tardive dyskinesia (TD) - The risk of developing TD and the potential for it to become irreversible may increase as the duration of treatment and the total cumulative dose increase. Prescribing should be consistent with the need to minimize TD. If signs and symptoms appear, discontinuation should be considered since TD may remit, partially or completely



Hyperglycemia and diabetes mellitus-Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including ABILIFY. Patients with diabetes should be monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. There have been few reports of hyperglycemia with ABILIFY



ABILIFY may be associated with orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.



As with other antipsychotic drugs, ABILIFY should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.



Like other antipsychotics, ABILIFY may have the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are certain ABILIFY does not affect them adversely.



Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.



Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY; use caution in patients at risk for aspiration pneumonia.



The possibility of a suicide attempt is inherent in psychotic illnesses, bipolar disorder, and major depressive disorder, and close supervision of high-risk patients should accompany drug therapy.



Physicians should advise patients to avoid alcohol while taking ABILIFY.



Strong CYP3A4 or CYP2D6 inhibitors increase ABILIFY drug concentrations when used concomitantly.



CYP3A4 inducers decrease ABILIFY drug concentrations when used concomitantly.



Commonly observed adverse reactions (greater than or equal to 5% incidence and at least twice the rate of placebo for ABILIFY vs placebo, respectively):



* Adult patients with bipolar mania: constipation (13% vs 6%), akathisia (15% vs 3%), sedation (8% vs 3%), tremor (7% vs 3%), restlessness (6% vs 3%), and extrapyramidal disorder (5% vs 2%)



* Pediatric patients (10 to 17 years) with Bipolar I Disorder: somnolence (23% vs 3%), extrapyramidal disorder (20% vs 3%), fatigue (11% vs 4%), nausea (11% vs 4%), akathisia (10% vs 2%), blurred vision (8% vs 0%), salivary hypersecretion (6% vs 0%), and dizziness (5% vs 1%)



* Adult patients with agitation associated with bipolar mania: nausea (9% vs 3%)



Please see FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, for ABILIFY.



About Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb



Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collaborative partners in the development and commercialization of ABILIFY in the United States and major European countries.



ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka - people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment. The Otsuka Pharmaceutical Group comprises



99 companies and employs approximately 31,000 people in 18 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned U.S. $7.2 billion in annual revenues in fiscal 2006.



Bristol-Myers Squibb is a global biopharmaceutical and related healthcare products company whose mission is to extend and enhance human life.



For more information and FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, visit: abilify/



Visit Otsuka Pharmaceutical Co., Ltd. at: otsuka-global/



Visit Bristol-Myers Squibb at: bms/



* The Y-MRS is a standard measure that is an 11-item rating scale used by healthcare providers to assess the scope and severity of manic symptoms.(1) Y-MRS Total Scores range from 0 (no manic symptoms) to 60 (severe mania).(2)
*(1) Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity, and sensitivity. Br J Psychiatry. 1978; 133:429-435.
*(2) Rush AJ, et al. Handbook of Psychiatric Measures. Washington, DC: American Psychiatric Association;2000.



References



(1) Kumra S, Oberstar JV, Sikich L, Findling RL, McClellan JM, Vinogradov S, Schulz SC. Efficacy and Tolerability of Second-Generation Antipsychotics in Children and Adolescents With Schizophrenia. Schizophrenia Bulletin. Published online October 8, 2007.
(2) IMS Auditrac NGPS: ABILIFY total monthly retail prescriptions: Data accessed December 2007.



February 2008 0308N-0662



Additional Contacts



Hideki Shirai

Otsuka Pharmaceutical Co., Ltd



Sonia Choi/Communications

Bristol-Myers Squibb Company



John Elicker/Investor Relations

Bristol-Myers Squibb Company



Source: Debra Kaufmann


Otsuka America Pharmaceutical, Inc.



View drug information on Abilify.

воскресенье, 19 июня 2011 г.

Brain Imaging Identifies Differences In Childhood Bipolar Disorder, ADHD

Researchers at the University of Illinois at Chicago are the first to use brain imaging to examine the effects of emotion on working memory function in children with pediatric bipolar disorder or attention deficit hyperactivity disorder.


The study is published in the October issue of the Journal of the American Academy of Child & Adolescent Psychiatry.


PBD and ADHD are very severe developmental disorders that share behavioral characteristics such as impulsivity, irritability and attention problems.


Using functional magnetic resonance imaging, researchers at UIC examined the brain activity of children as they performed a working memory task while viewing faces with different emotions, such as angry, happy or neutral expressions.


The children, ages 10 to 18, were asked to remember the faces and to press a button in the MR-scanner if they saw the same face that was presented two trials earlier. The study involved 23 non-medicated children with bipolar disorder, 14 non-medicated children with ADHD and 19 healthy controls.


"It's a simple yet elegant working memory test that tells us a lot about how their brain remembers stimuli like faces or objects," said Alessandra Passarotti, assistant professor of psychiatry at UIC and lead author of the study. "We also added in an emotional component -- because both disorders show emotional deficits -- to study how their working memory is affected by emotional challenge."


The researchers found that while both disorders show dysfunction in the prefrontal cortex relative to healthy controls, the ADHD group had the most severe dysfunction in this important region. The prefrontal cortex controls behavior, such as impulsivity, and executive function, as well as complex cognitive processes such as working memory, attention and language.


From a treatment, learning and intervention perspective, the next step for researchers and clinicians is to figure out how to help patients use their prefrontal cortex, Passarotti said.


The researchers also found that while the ADHD group had greater dysfunction in working memory circuits in the brain, the bipolar group had more deficits in regions of the brain involved in emotion-processing and regulation.


Now that researchers are starting to differentiate between the two disorders at a brain network level, rather than just at a behavioral level, the long-term goal is to develop diagnostic tests based on neurological and behavioral markers of illness that can be used in a clinical setting. Currently patients are diagnosed using clinical measures, questionnaires, behavior scales and interviews with parents.


It is difficult for physicians to differentiate between the two disorders behaviorally, which may lead to an incorrect diagnosis and wrong medications, a worsening of symptoms, and greater frustration for children and parents, said Passarotti, a researcher in UIC's Institute for Juvenile Research.


She said that while researchers still do not understand all of the neurological deficits that characterize ADHD and PBD profiles, they know that drug treatment that works for ADHD does not work for bipolar disorder.


"In fact, if you give a stimulant to a child with bipolar disorder, they become more manic, and this makes their illness even worse, whereas if you give the mood-regulation medicine commonly prescribed for PBD to a child with ADHD, they still show a lot of attention deficits and do not show any improvement," Passarotti said.


"Our hope is that by better differentiating between these two severe developmental illnesses, we can help develop more accurate diagnoses and more targeted treatments for PBD and ADHD."


Co-authors of the study are Dr. Mani Pavuluri, the Berger-Colbeth Term Chair in Child Psychiatry and director of the Pediatric Brain Research and Intervention Center at UIC, and John Sweeney, professor of psychiatry, neurology and psychology and director of the Center for Cognitive Medicine at UIC.


Source: University of Illinois at Chicago

суббота, 18 июня 2011 г.

Bipolar Disorder Genes, Pathways Identified By Indiana University Neuroscientists

Neuroscientists at the Indiana University School of Medicine have created the first comprehensive map of genes likely to be involved in bipolar disorder, according to research published online Nov. 21 in the American Journal of Medical Genetics.


The researchers combined data from the latest large-scale international gene hunting studies for bipolar disorder with information from their own studies and have identified the best candidate genes for the illness.


The methodology developed at the IU Institute of Psychiatric Research enabled Alexander B. Niculescu III, M.D., Ph.D., and his team to mine the data from the genome-wide association studies and other study results on the levels of gene activity in human blood samples and in animal models. Genes with the highest levels of prominence were determined to be the most active in contributing to the disorder.


The researchers also were able to analyze how these genes work together and created a comprehensive biological model of bipolar disorder.


"Based on our work, we now project that there will be hundreds of genes - possibly as much as 10 percent of the human genome - involved in this illness," said Dr. Niculescu, who is an assistant professor of psychiatry and director of the laboratory of neurophenomics at the IU School of Medicine. "Not all genetic mutations will occur in every individual with bipolar disorder. Different individuals will have different combinations of genetic mutations. This genetic complexity is most likely what made past attempts to identify genes for the disorder through genetic-only studies so difficult and inconsistent."


Dr. Niculescu compared the process to a Web search. "The process was similar to a Google approach, the more links there are to a page on the Internet, the more likely it is to come up at the top of your search list. The more experimental lines of evidence for a gene, the higher it comes up on your priority list of genes involved in the disorder."


Until now there have been few statistically significant findings in searches of the human genome as it applies to bipolar disorder, he said.


"By integrating the findings of multiple studies, we were able to sort through, identify genes that were most likely to be involved in bipolar disorder, and achieve this major breakthrough in our understanding of the illness," Dr. Niculescu said.


Bipolar disorder, sometimes called manic depression, affects nearly 2.3 million Americans. A serious illness, people who suffer from it can experience mild or dramatic mood swings, shifts in energy and a diminished capacity to function.


Dr. Niculescu, a practicing psychiatrist and a molecular geneticist, said this work opens exciting avenues for psychiatric researchers and clinicians, as well as for patients and their families.
"First and foremost, these studies will lead to a better understanding of bipolar and related disorders," he explained. "Second, the researchers now plan to study individuals to see which combination of genes is present in individuals to come up with a genetic risk score."


The goal, he said, is to be able to apply the risk score to test individuals even before the illness manifests itself for preventive measures - lifestyle changes, counseling, low-dose medications - or to delay or stop the illness from developing.


"Third, in individuals who already have the illness, genetic testing in combination with blood biomarkers for the disease, could help determine which treatments works best so personalized treatments could be developed," Dr. Niculescu said.


The research was done in collaboration with colleagues at the Scripps Research Institute, the University of California- San Diego, SUNY Upstate medical University and the National Institute of Mental Health. IU researchers involved were Helen Le-Niculescu, Ph.D., John I. Nurnberger, M.D., Ph.D., Meghana Bhat, M.D., and Sagar Patel.


Grant funding for the research was provided by National Institute of Mental Health.


Indiana University School of Medicine

medicine.iu

пятница, 17 июня 2011 г.

New Analysis Highlights Potential Of SEROQUEL For Long-term Treatment Of Bipolar Disorder

Results from a new analysis of two major clinical trials have shown that patients with bipolar disorder who received long-term treatment with SEROQUEL (quetiapine fumarate) plus a mood stabiliser were significantly less likely to have a mood event (manic, mixed or depressed) than patients on a mood stabiliser alone.1 The data, which highlight the potential of SEROQUEL for maintenance therapy of patients with bipolar I disorder, were presented on Sunday, 27 January 2008 at the 3rd Biennial Conference of the International Society for Bipolar Disorders (ISBD) in Delhi, India.



The new analysis1 was based on pooled results from two large-scale, international, double-blind studies (studies 126 and 127)2,3 that investigated the time to recurrence of a mood event in patients with bipolar I disorder. After achieving 12 weeks of clinical stability, 1334 patients were randomised to maintenance treatment with SEROQUEL (400-800 mg/day) plus lithium or divalproex, or placebo in combination with lithium or divalproex for up to 104 weeks. SEROQUEL combination treatment produced a significant 70% reduction in the risk of recurrence of a mood event compared with placebo plus lithium or divalproex (hazard ratio 0.30; p








Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 25 million* patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 77 countries for the treatment of bipolar mania, and in 11 countries including the US for the treatment of bipolar depression. Once daily SEROQUEL® XR (quetiapine fumarate extended release tablets) was launched for the treatment of schizophrenia in the US in 2007, and its clinical development program and planned regulatory filings extend through bipolar disorder to major depressive disorder (MDD) and generalised anxiety disorder (GAD).



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 $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.



SEROQUEL XR is a trademark of the AstraZeneca group of companies.



References


1. Brecher M, et al. Quetiapine in the maintenance treatment of bipolar I disorder: combined data from two long-term phase III studies. Presented at the Conference of the International Society for Bipolar Disorders, Delhi, India, 27-30 January, 2008.


2. Vieta E, et al. Efficacy and safety of quetiapine in combination with lithium/divalproex as maintenance treatment for bipolar I disorder. Presented at the Conference of the International Society for Bipolar Disorders, Delhi, India, 27-30 January, 2008.


3. Suppes T, et al. Maintenance treatment in bipolar I disorder with quetiapine concomitant with lithium or divalproex: a placebo-controlled, randomized multicenter trial. Presented at the Conference of the International Society for Bipolar Disorders, Delhi, India, 27-30 January, 2008.



* This estimate is based upon: (1) assumptions as to persistence (the number of prescriptions per patient) based upon 2002 market research; and (2) projections of prescriptions since launch based upon information available in the US and 13 of the 50 other countries in which SEROQUEL is marketed.


astrazeneca


View drug information on Seroquel.

четверг, 16 июня 2011 г.

Breast Cancer Drug Tamoxifen May Decrease Mania Of Bipolar Disorder

The drug tamoxifen is usually used to treat breast cancer, but
researchers say that it also may reduce symptoms of mania in people
with bipolar disorder. An article summarizing the small, three-week
trial of tamoxifen is published in Archives of General
Psychiatry.



As a treatment for breast cancer, tamoxifen impacts the way in which
the hormone estrogen works in the body. In addition, tamoxifen works
against the actions of the protein kinase C family of enzymes. People
who have bipolar disorder and related dysfunctions - ability to be
distracted, poor judgment-making abilities, and disorganized thoughts -
have been associated with abnormal activity levels of these enzymes.



Patients with bipolar disorder often have mania, characterized by
impulsive behavior, hyperactivity, and disconnected thoughts. Previous
animal studies and human pilot trials have recommended tamoxifen as an
effective treatment for these abnormally elevated moods.



To test tamoxifen as a treatment, AysegГјl Yildiz, M.D. (Dokuz EylГјl
University Medical School, Izmir, Turkey) and colleagues conducted a
clinical trial. The study consisted of 66 patients between 18 and 60
years old. All patients were diagnosed with bipolar disorder and at the
time were experiencing mania or a mixed state that included mania as
one component. The researchers randomly assigned participants to take
either a) tamoxifen (40 milligrams to 80 milligrams
per day) or b) identical placebo tablets twice
daily for up to three weeks. All patients received up to 5 milligrams
per day of lorazepam, a sedative that helps control symptoms.



Of the 66 patients who began the study, 50 patients completed the
21-day trial - 29 from the tamoxifen group and 21 from the placebo
group. Results at the end of three weeks are summarized below:


Tamoxifen takers scored significantly lower on tests
measuring the severity of mania
Placebo takers had mania scores that slightly increased
48% of patients taking tamoxifen responded to the drug (a
reduction of at least half in mania scores)
5% of patients taking placebo responded to the drug
28% of tamoxifen takers vs. zero placebo takers had mania
scores low enough for it to be considered in remission
Tamoxifen patients used less lorazepam during the study
(averaging 25.2 mg compared to 41.8 mg)

The authors state that tamoxifen and the placebo were well-tolerated.
"Moreover, all subjects used less lorazepam as the trial progressed,
and the rate of decrease was 2.5 times greater with tamoxifen."



"The findings encourage further clarification of the role of protein
kinase C in the pathophysiologic mechanism of bipolar 1 disorder and
development of novel anti-protein kinase C agents as potential
antimanic or mood-stabilizing agents," conclude the authors.



Protein Kinase C Inhibition in the Treatment of Mania: A
Double-blind, Placebo-Controlled Trial of Tamoxifen

AysegГјl Yildiz; Sebnem Guleryuz; Donna Pauler Ankerst; Dost-ngГјr;
Perry F. Renshaw

Archives of General Psychiatry. (2008).
65(3):255-263.

Click
Here to View Abstract



Written by: Peter M Crosta




среда, 15 июня 2011 г.

Memory Pharmaceuticals Initiates Phase 2a Trial Of MEM 1003 In Bipolar Disorder

Memory Pharmaceuticals Corp. (Nasdaq: MEMY) today announced the dosing of the first subject in a Phase 2a trial of MEM 1003 in patients with acute mania in bipolar disorder. The Company is conducting the trial as part of its
agreement with The Stanley Medical Research Institute (SMRI), which is
providing funding support for this Phase 2a clinical trial of MEM 1003.


The multicenter, double-blind, randomized, placebo-controlled study
will evaluate the safety and efficacy of MEM 1003 for the treatment of
acute mania in bipolar disorder. Approximately 60 subjects in the United
States will be enrolled in the trial and randomized to receive MEM 1003 or
placebo for a 21-day treatment period, which will be followed by an
optional open-label four-week treatment period. Subjects in the MEM 1003
group will receive 60 mg of MEM 1003 twice a day, with up to two dose
escalations, from 60 to 120 mg twice a day on the second day of treatment
and from 120 to 180 mg twice a day on the third day of treatment. The
primary outcome measure of the trial is the change in the Young Mania
Rating Scale (YMRS) at 21 days.


"This clinical trial is the first large-scale controlled study of a
calcium channel blocker in bipolar disorder and is also an important
milestone for Memory Pharmaceuticals, as we expand our clinical experience
with MEM 1003 and explore the potential of this promising compound in this
indication," said Stephen R. Murray, M.D., Ph.D., Vice President of
Clinical Development. "In clinical practice, other calcium channel
modulators have shown promise in the treatment of bipolar disorder, but the
blood pressure lowering effects of these drugs have limited further
development. We believe that MEM 1003 has been optimized for central
nervous system activity and has the potential to improve the mood swings
characterized by this disorder at doses below those that will lower blood
pressure. We look forward to completing this trial in the first half of
2007."


Under the terms of the agreement with SMRI, Memory Pharmaceuticals
could receive up to $3.2 million from SMRI to fund a Phase 2a clinical
trial of MEM 1003 in bipolar disorder. In December 2005, SMRI purchased
440,367 newly issued shares of the Company's common stock at a price of
$2.18 per share, constituting $960,000 of the total possible funding to
Memory Pharmaceuticals under the agreement. Memory Pharmaceuticals is
eligible to receive up to an additional $2.24 million of funding from SMRI
upon the achievement of milestones related to this Phase 2a trial. These
funds will be repayable to SMRI in the form of royalties, up to a specified
maximum amount, on any future sales of MEM 1003 for the treatment of
bipolar disorder or schizophrenia.


MEM 1003 is a neuronal L-type calcium channel modulator that Memory
Pharmaceuticals is developing for the treatment of Alzheimer's disease and
bipolar disorder. By blocking L-type calcium channels, MEM 1003 may
regulate the flow of calcium and reestablish normal levels of calcium,
which may correct or prevent the severe mood swings that characterize
bipolar disorder.















About the Company


Memory Pharmaceuticals Corp., a biopharmaceutical company, is focused
on developing innovative drugs for the treatment of debilitating CNS
disorders such as Alzheimer's disease, schizophrenia, depression and
bipolar disorder. For additional information, please visit our website
memorypharma.


Safe Harbor Statement


This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks and uncertainties. All statements, other than statements
of historical facts, regarding management's expectations, beliefs, goals,
plans or Memory Pharmaceuticals' prospects, future financial position,
future revenues and projected costs should be considered forward-looking.
Readers are cautioned that actual results may differ materially from
projections or estimates due to a variety of important factors, including
the risks and uncertainties associated with: obtaining additional financing
to support Memory Pharmaceuticals' R&D and clinical activities and
operations; conducting preclinical and clinical trials of Memory
Pharmaceuticals' drug candidates that demonstrate these candidates' safety
and effectiveness; obtaining regulatory approvals to conduct clinical
trials and to commercialize Memory Pharmaceuticals' drug candidates; Memory
Pharmaceuticals' ability to enter into and maintain collaborations with
third parties for its drug development programs; Memory Pharmaceuticals'
dependence on its collaborations and its license relationship with Bayer;
achieving milestones under Memory Pharmaceuticals' collaborations; Memory
Pharmaceuticals' dependence on third-party preclinical or clinical research
organizations, manufacturers and consultants; and protecting the
intellectual property developed by or licensed to Memory Pharmaceuticals.
These and other risks are described in greater detail in Memory
Pharmaceuticals' filings with the Securities and Exchange Commission.
Memory Pharmaceuticals may not actually achieve the goals or plans
described in its forward-looking statements, and investors should not place
undue reliance on these statements. Memory Pharmaceuticals disclaims any
intent or obligation to update any forward-looking statements as a result
of developments occurring after the date of this press release.


Memory Pharmaceuticals Corp

memorypharma

вторник, 14 июня 2011 г.

First Lords Vote To Amend Mental Health Bill Hailed By The Mental Health Alliance, UK

Members of the Mental Health Alliance congratulated the House of Lords on its first amendment to a flawed and disappointing Mental Health Bill.


In its second day in Committee on Wednesday, the House of Lords voted to amend the Bill to stop people who have their full decision-making abilities and have committed no offence, from being sectioned.


Welcoming the vote to loosen needless powers of compulsion in the treatment of mentally ill patients, Alliance vice-chair Rowena Daw said:


"The House of Lords has voted to end a major inequality for people with a mental illness. People with physical illnesses cannot be forced to take medical treatment if they have their full decision-making ability, and nor should those with a mental illness.


"We are heartened by the diligent and serious consideration the House of Lords is giving to this Bill. The Bill is in need of a complete overhaul. We hope that today's vote marks the start of that process in Parliament."


The Mental Health Bill was published on 17 November 2006. Committee Stage in the House of Lords began on 8 January.


The Mental Health Alliance is a coalition of 78 organisations working together to secure better mental health legislation for England and Wales. mentalhealthalliance.uk

понедельник, 13 июня 2011 г.

New Certified Reference Materials Offer Greater Certainty In Monitoring 3 Therapeutic Medications

To help bring greater certainty to the measurement of medication levels in a patient's bloodstream for three drugs with narrow therapeutic ranges, the U.S. Pharmacopeial Convention (USP) is releasing new certified reference materials (CRMs).



The three new CRMs are for carbamazepine, an anticonvulsant and mood stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder; phenytoin, commonly used as an antiepileptic; and theophylline, used in the treatment of respiratory diseases. These three drugs are among a group of medicines that are often monitored in the bloodstream of patients that have been prescribed the drugs. Such medicines may need to be carefully monitored for a number of reasons, including a narrow therapeutic range or risk of toxicity. Therapeutic drug monitoring may also be necessary for drugs that are intended to maintain the absence (as opposed to the presence) of a medical condition, such as seizures.



CRMs represent an important step forward for USP reference standards, which are the physical materials used to demonstrate compliance to written USP standards designating a medicine and its ingredients' identity, quality, purity, strength and consistency. CRMs are reference standards accompanied by a certificate of analysis. A CRM is rigorously tested for one or more chemical or physical properties (such as purity). A property value with associated uncertainties certified to be true based on these tests is assigned to the CRM after a thorough statistical treatment of the data. The path of metrological traceability, which provides information on how the measurement was made and which standards were used to support the measurement, is included in the Certificate of Analysis, as well as the estimated level of uncertainty associated with the assigned value. This added information regarding uncertainties and traceability is provided for users of the reference materials. Procedures for determining compliance with USP compendial quality standards remain unchanged since, as stated on the Certificates of Analysis, the associated uncertainties are not used as part of the calculation value for quantitative USP-NF applications.



The new CRMs will be used by the in vitro diagnostic device industry, which manufactures medical devices that examine specimens derived from the human body (e.g., blood or tissue donations) to provide information related to a physiological or pathological state or to monitor therapeutic measures. Requirements in Europe state that all measurements should be traceable to standards of a "higher metrological order," that is, more certain measurements. The International Organization for Standardization (ISO) states that, where possible, such standards should be CRMs. USP is the first global pharmacopeia to be ISO-certified as a producer of chemical CRMs.



"In releasing these three new CRMs, USP is meeting the needs of the multi-national in vitro diagnostic device industry," said William Koch, Ph.D., USP's chief metrology officer. "For these three products, a higher degree of certainty in measurement is extremely important. In Europe specifically, regulations support use of CRMs for in vitro diagnostic devices. However, this is useful for manufacturers of these medicines worldwide."



Source: Francine Pierson


US Pharmacopeia

воскресенье, 12 июня 2011 г.

Botox Into Frown Lines Can Help Patients With Major Depression

A trial carried out by Dr. Eric Finzi and Dr. Erika Wasserman found that treating clinically depressed patients with botox on the frown lines of their faces actually got rid of their depression.


In their abstract report, found in the journal Dermatologic Surgery, the researchers indicate that major depression is a common and serious disease. Major depression is sometime resistant to drug therapy and psychotherapeutic treatment approaches.


In this trial, the researchers wanted to evaluate how effective Botulinim Toxin A treatment of glabellar frown lines might be for patients with major depression. They used a small open pilot trial.


They selected ten patients who had ongoing major depression despite drug and psychotherapeutic treatment. They were evaluated with the Beck Depression Inventory II (BDI-II) before receiving botox treatment on their frown lines.


Two months after the botox treatment, all ten patients were re-evaluated clinically and with the BDI-II.


Nine patients were no longer depressed two months after botox treatment on their frown lines. One patient experienced no improvement in mood.


The researchers concluded that botox treatment on frown lines may be an effective treatment for patients with major depression who have not responded to routine pharmacologic and psychotherapeutic treatment approaches.


Dr. Finzi has applied for a patent for this treatment for depression.


Link to Abstract in Dermatologic Surgery Journal


Written by:




View drug information on Botox.



суббота, 11 июня 2011 г.

Wiring in a Cone-Only Retina

Recruitment of the Rod Pathway by Cones in the Absence of Rods Enrica Strettoi, Alan J. Mears, and Anand Swaroop.


In the retina, rods and cones form a distinct wiring diagram with specific second- and third-order neurons. Although the pathways eventually overlap at the ganglion cell layer, they are segregated at their initial inputs into rod- and cone-specific bipolar cells.


But what happens when rods, normally constituting >90% of photoreceptors, do not form and thus all photoreceptors are cones?


Amazingly the morphology, connectivity and transmission of rod bipolar neurons as well as horizontal and AII amacrine cells that normally receive rod input appeared to be neatly maintained when rods were replaced with cones.

The cone-only retinas were also light-sensitive.


Contact: Dawn McCoy

dawnsfn

202-462-6688

Society for Neuroscience

пятница, 10 июня 2011 г.

Alexza Initiates Second Phase 3 Clinical Trial For AZ-004 (Staccato(R) Loxapine)

Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has initiated
its second Phase 3 clinical trial with AZ-004 (Staccato(R) loxapine).
AZ-004 is an inhalation product candidate being developed for the treatment
of acute agitation in patients with schizophrenia or bipolar disorder.
Alexza believes the novel, non-invasive nature and rapid pharmacokinetic
(PK) properties resulting from inhaled loxapine administration via the
Staccato system have the potential to make AZ-004 a viable product to treat
acute agitation. AZ-004 is being developed through Symphony Allegro, a
product development partnership formed between Alexza and Symphony Capital,
LLC.


"We are excited to be advancing our AZ-004 NDA plan with the start of
the second Phase 3 clinical trial this year. We look forward to enrolling
this Phase 3 clinical trial as quickly as possible, and also releasing the
initial results from our first Phase 3 study before the end of September,"
said Thomas B. King, Alexza President and CEO. "This year is a transitional
year in our history, as we move into the commercial planning for the
manufacturing, quality systems, regulatory submissions, and potential sales
and marketing of AZ-004."



AZ-004 Second Phase 3 Clinical Trial Design



The second AZ-004 Phase 3 clinical trial is designed to enroll
approximately 300 patients diagnosed with bipolar I disorder and acute
agitation at 18 U.S. clinical centers. The trial is an in-clinic,
multi-center, randomized, double-blind, placebo-controlled study and will
test AZ-004 at two dose levels, 5 and 10 mg. Patients may receive up to 3
doses of study drug in a 24-hour period, depending on their clinical
status. Patients eligible for the study include those who are admitted
through an emergency department and those who are already in-patients in a
hospital setting, as long as they have acute agitation at the time of
patient randomization. This study is the first AZ-004 study enrolling
bipolar disorder patients. Alexza projects that this second Phase 3
clinical trial will take approximately 12 months to complete patient
enrollment.



The primary endpoint for the study is the change from baseline in the
PANSS (Positive and Negative Symptom Scale) Excited Component (also known
as PEC) score, measured at 2 hours after the first dose. Various
assessments of a patient's agitation state will be conducted at serial time
points using standard agitation scales over the first 4-hour post-dose time
period, with follow-up assessments at the end of the 24-hour study period.
Side effects will be recorded throughout the 24-hour period.



About Acute Agitation



Acute agitation, characterized by unpleasant arousal, tension,
irritability and hostility, is one of the most common and severe symptoms
of many major psychiatric disorders, including schizophrenia and bipolar
disorder. According to the National Institute of Mental Health (NIMH),
bipolar disorder affects about 5.7 million American adults while
schizophrenia afflicts about 2.4 million people in the United States.
Market research among physicians and health-care providers indicates that
over 90% of these patients will experience agitation during their lifetime
and that about 70% of those who experience agitation will have one to six
episodes per year.
















Agitated patients are often treated in an emergency department, and are
also treated as in-patients in psychiatric hospitals or psychiatric units
in standard hospitals. Market research among psychiatrists indicates that
these physicians currently treat acute agitation with intramuscular (IM)
injections, rapid-dissolve tablets or standard tablets. IM injections are
invasive, can be disconcerting to patients as they often require the use of
restraints, and can be dangerous to the medical personnel while they
attempt to inject the patient. IM injections can also take up to 60 minutes
to work. Oral tablets provide convenience of dosing alternatives, but have
a slower onset of action. This market research has also identified speed of
onset as an important factor that affects the choice of therapy for
treating acute agitation. Alexza believes that many patients with
schizophrenia or bipolar disorder can make informed decisions regarding
their treatment in an acute agitative state and would prefer a
rapid-acting, noninvasive treatment.



In summary, Alexza believes there is a significant unmet medical need
for an acute agitation treatment option that will provide a fast onset of
effect, that is noninvasive and safer to administer, and that allows
patients to be active participants in choosing acceptable treatment
options.



About AZ-004



AZ-004 is the combination of Alexza's proprietary Staccato system with
loxapine, a drug belonging to the class of compounds known generally as
antipsychotics. The Staccato system is a hand-held, chemically-heated,
single dose inhaler designed to generate and deliver excipient-free drug
aerosol for deep lung delivery that results in IV-like pharmacokinetics.
Alexza has completed four clinical trials with AZ-004, including a 50
subject Phase 1 study in healthy volunteers, a 129 patient Phase 2 study in
agitated schizophrenic patients, a 32 patient multiple-dose tolerability
and PK study in non-agitated schizophrenic patients, and a 344 patient
Phase 3 study in agitated schizophrenic patients. Alexza projects that the
initial results from the first Phase 3 study will be reported before the
end of September 2008.



The Company believes that the unique delivery of loxapine via the
Staccato system will provide rapid onset of drug effect, as measured by a
reduction in the signs and symptoms of acute agitation. In March 2007,
Alexza announced positive initial results from a multi-center, randomized,
double-blind, placebo-controlled Phase 2 clinical trial in 129 patients in
an in-patient clinical setting. The 10 mg dose of AZ-004 met the primary
endpoint of the clinical trial, which was a statistically significant
reduction in the measure of agitation from baseline to the 2-hour post-dose
time point, as compared to placebo. The 10 mg dose of AZ-004 also exhibited
a rapid onset of effect, with a statistically significant improvement in
the PEC scores at 20 minutes post-dose, as compared to placebo. The
effectiveness of the AZ-004 10 mg dose was sustained throughout the 24-hour
study period, as compared to placebo.



About Alexza Pharmaceuticals, Inc.



Alexza Pharmaceuticals is an emerging specialty pharmaceutical company
focused on the development and commercialization of novel, proprietary
products for the treatment of acute and intermittent conditions. The
Company's technology, the Staccato system, vaporizes unformulated drug to
form a condensation aerosol that allows rapid systemic drug delivery
through deep lung inhalation. The drug is quickly absorbed through the
lungs into the bloodstream, providing speed of therapeutic onset that is
comparable to intravenous administration, but with greater ease, patient
comfort and convenience.



Alexza has six product candidates in clinical development. Alexza's
lead program, AZ-004 (Staccato loxapine) for the treatment of acute
agitation in schizophrenic or bipolar disorder patients, is in Phase 3
testing and completed the enrollment of its first Phase 3 clinical trial in
June 2008. AZ-001 (Staccato prochlorperazine) for the acute treatment of
migraine headaches has completed Phase 2 testing. AZ-104 (Staccato
loxapine) for the acute treatment of migraine headaches and AZ-002
(Staccato alprazolam) for the acute treatment of panic attacks associated
with panic disorder are in Phase 2 testing. Product candidates in Phase 1
testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough
pain, which is partnered with Endo Pharmaceuticals in North America, and
AZ-007 (Staccato zaleplon) for the treatment of insomnia. More information,
including this and past press releases from Alexza, is available online at
alexza.



Safe Harbor Statement



This press release includes forward-looking statements regarding the
development, therapeutic potential and safety of AZ-004, the development of
the Company's product candidates, projected clinical trial enrollment and
data reporting timelines, and safety of the Company's products and
technologies. Any statement describing the Company's expectations or
beliefs is a forward-looking statement, as defined in the Private
Securities Litigation Reform Act of 1995, and should be considered an
at-risk statement. Such statements are subject to certain risks and
uncertainties, particularly those inherent in the process of developing and
commercializing drugs. The Company's forward-looking statements also
involve assumptions that, if they prove incorrect, would cause its results
to differ materially from those expressed or implied by such
forward-looking statements. These and other risks concerning Alexza's
business are described in additional detail in the Company's Annual Report
on Form 10-K for the year ended December 31, 2007, and the Company's other
Periodic and Current Reports filed with the Securities and Exchange
Commission, including the risks under the headings: "Failure or delay in
commencing or completing clinical trials for our product candidates could
harm our business" and "If our product candidates do not meet safety and
efficacy endpoints in clinical trials, they will not receive regulatory
approval, and we will be unable to market them." Forward-looking statements
contained in this announcement are made as of this date, and we undertake
no obligation to publicly update any forward-looking statement, whether as
a result of new information, future events or otherwise.


Alexza Pharmaceuticals, Inc.

alexza



View drug information on Prochlorperazine.

четверг, 9 июня 2011 г.

Yale Findings Hold Promise For Stopping Progression Of Bipolar Disorder

Changes in the brain that are important indicators of bipolar disorder are not prominent until young adulthood and are reduced in persons taking mood-stabilizing medications, Yale School of Medicine researchers report this month in Biological Psychiatry.



The researchers used magnetic resonance imaging to measure a part of the brain that regulates emotions, the ventral prefrontal cortex, that lies above the eyes. The changes in persons with bipolar disorder were not prominent until young adulthood, suggesting that the illness progresses during the teenage years. Bipolar disorder is also known as manic-depressive illness.



"The brain changes were diminished in persons with bipolar disorder who were taking mood-stabilizing medications," said Hilary Blumberg, M.D., associate professor in the Department of Psychiatry and director of Yale's Mood Disorders Research Program. "This brings hope that it may someday be possible to halt the progression of the disorder."



Blumberg added, "Research to understand bipolar disorder in youths is especially important because of their high risk for suicide."



Bipolar disorder is characterized by episodes that range from emotional highs, or manias, to emotional lows, or depressions. Extreme manic highs can be associated with over-spending, impulsiveness on the job or at school, and risky behaviors, including sexual indiscretions that can lead to loss of important relationships. Blumberg said in depressive episodes individuals may "take to bed" or, in severe cases, try to take their own lives.







The research was conducted at Yale in collaboration with co-authors John Krystal, M.D., Ravi Bansal, Andrйs Martin, M.D., James Dziura, Kathleen Durkin, Laura Martin, Elizabeth Gerard, M.D., Dennis Charney, M.D., and Bradley Peterson, M.D.



Biological Psychiatry: Published online January 20, 2006



Contact: Jacqueline Weaver

jacqueline.weaveryale

Yale University

среда, 8 июня 2011 г.

Latest NIMH Study On Bipolar Disorder - National Alliance On Mental Illness Statement

Statement of Ken Duckworth, M.D., Medical Director National Alliance on Mental Illness (NAMI)


Today the Archives of General Psychiatry published a study on the effectiveness of psychosocial treatments for bipolar disorder, "Psychosocial Treatments for Bipolar Disorder." This is a follow up study to one released last Thursday in the New England Journal of Medicine on the effects of antidepressants in the treatment of bipolar disorder. Both studies, called STEP-BD, were funded by the National Institute of Mental Health.


Bipolar disorder is a complex medical illness of the brain that affects 5.7 million Americans.


Ken Duckworth, M.D., medical director of the National Alliance on Mental Illness (NAMI) issued the following statement commenting on the studies:


"Researchers compared the two treatment models, one of which provided 'intensive psychotherapy', which included weekly sessions in family focused therapy, or interpersonal and social rhythm therapy, or cognitive behavioral therapy; versus 'collaborative care,' which provided three brief psycho educational interventions over a six week period. They found study subjects receiving intensive psychotherapy were 1.58 times more likely be clinically well in a given month and had higher rates of recovery than individuals only receiving collaborative care. This is a call to action for access to these hard-to-find interventions.


The implications of this study are twofold. First, there needs to be more training programs that offer these psychosocial interventions so mental health providers can provide quality care. Second, the study also reminds us of the importance of family in treating people living with bipolar disorder. People who had relationships with family members, in both the control group and the experimental group, had better long-term results with the involvement of their family members.


This study concludes what NAMI members have known for years - a combination of intensive psychosocial interventions and family involvement are both necessary ingredients for the best outcomes in bipolar disorder. Unfortunately many people who live with serious mental illnesses, like bipolar disorder, don't have access to the most basic care, much less the intensive psychosocial interventions recommended in the study.


The medication arm of the study, released last week in the New England Journal of Medicine, looked at two commonly prescribed antidepressants along with mood stabilizers for the symptoms of depression in individuals who have a diagnosis of bipolar disorder. The study found that the two antidepressants they studied did not work to relieve the depressive symptoms of the illness any better than placebo did for people with bipolar illness. The depressive phase of bipolar illness is notoriously difficult to treat, and more will have to be uncovered as to which pharmacologic strategies best complement the psychosocial treatments for this aspect of bipolar disorder. Most people with bipolar illness spend much more time in the depressive phase, so the need for more effective treatments is profound.


What we learn from these studies is that the treatment of bipolar disorder is an important public health concern, and one that demands individualized attention. We need to provide greater access to intensive psychotherapy to truly offer the hope of recovery to millions of Americans living with bipolar disorder."


On March 29, the New England Journal of Medicine published results from a study sponsored by the National Institute of Mental Health (NIMH) on treatment of bipolar disorder, finding that for depressed people who are taking a mood stabilizer, adding an antidepressants is no more effective than a placebo (sugar pill). Read more from NAMI about this study.


National Alliance on Mental Illness

вторник, 7 июня 2011 г.

New bipolar disorder drug approved by FDA

Eli Lilly Says It Wins FDA Approval for New Drug to Treat Depressive Phase of Bipolar Disorder


Eli Lilly and Co. on Monday said it has won regulatory approval to sell its new drug Symbyax to treat the depressive phase of bipolar disorder.


The U.S. Food and Drug Administration approved the drug, which is a combination of the active ingredients in two other drugs the anti-depressant Prozac and the anti-psychotic Zyprexa, which is used for treating manic stages of bipolar disorder.



Symbyax treats the depression stages of the illness without triggering mania, said Marni Lemons, a spokeswoman for the Indianapolis-based drug company.



'It's always been very challenging for physicians to treat the depressed phase without sending people with bipolar disorder from the depressed phase right into the manic phase,' Lemons said.



Symbyax will be available to physicians by mid- to late-January, Lemons said.



Some patients may be able to take Symbyax for the depressive stages of bipolar disorder and Zyprexa for the manic phases, she said.



Hemant K. Shah, an independent analyst from Warren, N.J., said the new drug would be 'incrementally important' for Eli Lilly.



'I'm not sure that this is going to be a big blockbuster by itself, but it will add it's ability to Zyprexa,' Shah said.



An estimated 2.5 million Americans have bipolar disorder, although some say the number is as high as 10 million.



Shah pointed out that 'that's a relatively narrow population.'



Lemons said Symbyax works faster than other drugs used to treat depression. That would be important because patients in bipolar disorder's depression stages are particularly prone to suicide attempts, she said.



'Traditional (antidepressants) like Prozac take several weeks to work,' Lemons said, adding that patients taking Symbyax can see results in about a week.



Lemons said she did not know the exact price of the drug, but said it would be comparable to Zyprexa.



Shares of Eli Lilly rose $1.00, or 1.4 percent, to close at $71.62 on the New York Stock Exchange.


View drug information on Prozac Weekly; Zyprexa.

понедельник, 6 июня 2011 г.

Capsules may be effective in treating bipolar disorder

University of North Carolina at Chapel Hill researchers have announced study results finding that a formulation of
three-beaded extended-release carbamazepine capsules (ERC-CBZ) was effective, safe and tolerable in the treatment of bipolar
I disorder and showed no clinically significant weight gain or changes in blood glucose between treatment groups.


The pooled data presented by UNC researchers today (Nov. 18) at the 17th annual U.S. Psychiatric and Mental Health Congress
in San Diego are results from two of the first trials to use an extended-release form of carbamazepine capsules manufactured
by Shire Pharmaceuticals.


"People affected by bipolar disorder experience intense highs and-or irritability, which may be followed or paired with
crippling lows. Bipolar patients also may be affected by additional disorders including anxiety disorders, attention deficit
disorder and substance abuse," said Dr. Richard H. Weisler, primary investigator of both clinical trials and adjunct
professor of psychiatry at UNC's School of Medicine.


"Many patients at present still either fail to respond or have trouble tolerating medications for their bipolar disorder. For
this reason, finding a treatment regimen that works effectively in both manic states and the large number of mixed patients
who are both seriously depressed and manic at the same time is a very important addition to our treatment options for
patients and their doctors."


Weisler also is adjunct assistant professor of psychiatry and behavioral sciences at Duke University Medical Center and has a
private practice in Raleigh.


More than 2 million American adults are estimated to have bipolar disorder in any given year. In fact, recent research
suggests approximately one in 30 adults suffer from bipolar disorder. Bipolar disorder, also known as manic-depressive
illness, is characterized by episodes of mania and depression while experiencing periods of normal mood in between. Although
bipolar disorder can have devastating effects on an individual's life, it is often not recognized as an illness and the
majority of people may suffer for years before it is properly diagnosed and treated.


"Proper diagnosis and earlier treatment can usually alter the course of the illness," said Weisler.


This analysis of pooled data resulted from two identically designed, three-week, double-blind, placebo-controlled phase 3
trials of ERC-CBZ monotherapy in patients initially requiring hospitalization. The trial involved 443 patients ages 18 to 76
years with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of bipolar disorder
(current episode manic or mixed) who were randomized to double-blind treatment with either ERC-CBZ or placebo.















Efficacy was assessed by Young Mania Rating Scale (YMRS), Clinical Global Impression-Severity (CGI-S), Clinical Global
Impression-Improvement (CGI-I), and Hamilton Depression Rating Scale (HDRS). Safety and tolerability were assessed by
measurements of weight, blood glucose, cholesterol and interval between heartbeats, as well as adverse event monitoring.



ERC-CBZ treatment was initiated at 200 milligrams twice daily and titrated, as necessary, by 200 milligrams per day up to
1,600 milligrams per day. The average final dose of ERC-CBZ was 700 milligrams per day, with many patients receiving 400 to
600 milligrams at final daily dose.


Of the 443 patients, 240 (54.2 percent) completed the study. Treatment with ERC-CBZ was associated with significant
improvements in mean YMRS total scores at all time points during the trial. At the end of the trial, significant reductions
in YMRS total scores were observed in both manic and mixed patients. Furthermore, significant improvements were shown in
CGI-I and CGI-S scores. Total score improvements in HDRS were observed in ERC-CBZ treated mixed patients at endpoint.



ERC-CBZ was generally well-tolerated in both manic and mixed bipolar patients. The 240 patients in the final group
demonstrated no clinically significant weight gain, no significant changes in blood glucose and intervals between heartbeats
between treatment groups, and no serious rashes, blood disorders or ECG adverse events. Treatment with ERC-CBZ caused a
modest increase in total cholesterol of 21.1 milligrams/deciliter of which about 20 percent was the beneficial HDL
cholesterol. Common treatment-emergent adverse events were mild to moderate in nature and included dizziness, somnolence,
nausea, vomiting and loss of coordination. However, these events were transient and most occurred during the first week of
treatment.


Of patients recruited into the trial, 79 percent were from the United States and 21 percent from India; and 58.5 percent were
white, 14.8 percent black and 26.7 percent were other ethnicities. The mean age of patients was 37.5 years of age, and 62
percent were male. Mixed presentation patients accounted for 34 percent and 62 percent of patients suffered from mania.



Weisler's co-authors in this study were Dr. R. Hirschfeld of the University of Texas Medical Branch at Galveston, Dr. A. J.
Cutler of the University of South Florida, Dr. T. Gazda of St. Luke's Medical Center, Dr. T. Ketter of Stanford University
School of Medicine, Dr. P. Keck of the University of Cincinnati College of Medicine; Dr. A. Swann of the University of Texas
Medical School at Houston and Dr. A. Kalali of Quintiles CNS Therapeutics in San Diego.


Funding for the study was provided by Shire.


Note: Weisler will present the findings of the new study from 3:45 p.m. to 6:45 p.m. Pacific time.


UNC School of Medicine contact: Stephanie Crayton, 919-966-2860 or scraytonunch.unc. UNC News Services contact: Deb
Saine, 919-962-8415 or deborah_saineunc.


Contact: Stephanie Crayton, UNC School of Medicine

919-966-2860

Porter Novelli

воскресенье, 5 июня 2011 г.

DBSA Anxiety, Depression Awareness Week Survey Underscores Strong Relationship Between Common Mental Disorders

People living with depression
or bipolar disorder are also likely to have significant problems with
anxiety, both diagnosed and undiagnosed, according to an online survey
conducted by the Depression and Bipolar Support Alliance (DBSA). The
nation's largest patient- run organization focusing on two of the most
prevalent mental illnesses conducted the survey to mark National Anxiety
and Depression Awareness Week, May 6-12.



The survey of nearly 800 people with depression or bipolar disorder
reveals telling indicators that reinforce a strong relationship between
anxiety and mood disorders, a fact not unknown to mental health researchers
and clinicians, but nevertheless important for people living with these
common conditions to fully understand.



According to the National Institute of Mental Health (NIMH),
approximately 24 million Americans live with a diagnosed mood disorder
while 40 million American adults are diagnosed with an anxiety disorder.
Most people deal with anxiety on some level from time to time, but anxiety
disorders are characterized by prolonged periods (at least six months) of
exaggerated worry and fearfulness that keep people from doing things most
others take for granted.



Common anxiety disorders include generalized anxiety disorder (GAD),
obsessive compulsive disorder (OCD), panic disorder, post-traumatic stress
disorder (PTSD) and social phobias.



Eighty-seven percent of survey respondents said they either had a
diagnosed anxiety disorder or an undiagnosed problem with anxiety. Those
findings echo the Bipolar Genetics Initiative study conducted by NIMH in
2006 that found more than 90 percent of people with panic disorder also had
some form of depression or bipolar disorder.



Respondents with both depressive and anxiety diagnoses cited
generalized anxiety disorder (68%), panic disorder (57%) and PTSD (30%) as
the most common anxiety conditions. Since some people are diagnosed with
more than one anxiety disorder, the survey allowed for multiple answers.
Seventy-three percent of respondents reported that their anxiety and mood
disorders were related, with 43 percent saying their anxiety worsened their
depressive illness and 30 percent reporting the opposite.



"For people living with our illnesses it's important to manage stress
and anxiety," said DBSA president Sue Bergeson. "Whether we have a
diagnosed anxiety disorder or not, it's imperative that we develop and
adhere to wellness plans and strategies that minimize stress so that we are
living full, happy and productive lives with the goal of full and sustained
recovery."



When asked about potential triggers that worsened their anxiety, survey
respondents most commonly cited disrupted sleep patterns (57%), stressful
social situations (51%) and being in crowded areas (43%). Other anxiety
inducing situations included workplace pressures, familial problems and
special occasions, such as holidays and birthdays.



While less than half of respondents (43%) expressed confidence that
their medications and/or treatment plans were effective in helping manage
anxiety, they were quick to acknowledge that medication was the most
important thing they did to treat their conditions. Nearly three quarters
(72%) of respondents said taking medication was the best way to alleviate
their symptoms. Other helpful activities cited included sleep or rest (56%)
and talk therapy (40%).



The findings from the survey reinforce much of the research done on the
relationship between anxiety and mood disorders. Monitoring sleep patterns
and being aware of the types of social situations that induce stress and
anxiety are good ways of managing the illnesses, Bergeson suggested.



"We can't view or treat these illnesses separately; we need to take a
holistic approach so that we are addressing anything and everything that
impedes recovery," she added. "Medication and therapy may be only part of
the equation; many people are relying on peer-led support groups, mood
trackers, journaling and other types of techniques and strategies to
achieve wellness."



For more information on mood and anxiety disorders, visit
DBSAlliance


Depression and Bipolar Support Alliance

dbsalliance

суббота, 4 июня 2011 г.

Excessive Inflammation During Stressful Situations Experienced By Depressed Patients

Individuals with major depression have an exaggerated inflammatory response to psychological stress compared to those who do not suffer from depression, according to a study by researchers at Emory University School of Medicine. Because an overactive inflammatory response may contribute to a number of medical disorders as well as to depression, the findings suggest that increased inflammatory responses to stress in depressed patients may be a link between depression and other diseases, including heart disease, as well as contributing to depression itself.



Results of the study, led by Andrew Miller, MD, and Christine Heim, PhD, of Emory's Department of Psychiatry and Behavioral Sciences, are published in the Sept. 1 issue of the American Journal of Psychiatry.



"Several examples of increased resting inflammation in depressed patients already exist in the literature, but this is the first time anyone has shown evidence to suggest that the inflammatory response to stress may be greater in depressed people," says Dr. Miller.



The study included 28 medically healthy male participants, half of whom were diagnosed with major depression and half of whom were not depressed. The participants were exposed to two moderately stressful situations during a 20-minute time period. Blood was collected every 15 minutes starting immediately before and then up to an hour and a half after the test to check for key indicators of inflammation. The researchers measured levels of a pro-inflammatory cytokine (a regulatory protein secreted by the immune system) called interleukin-6, and the activity of a pro-inflammatory signaling molecule in white blood cells called nuclear factor-kB.



While at rest (before the stress challenge), the depressed patients had increased inflammation relative to the control group. Both the depressed and the healthy groups showed an inflammatory response to the stress challenge, but people who were currently depressed exhibited the greatest increases of interleukin-6 and nuclear factor-kB.



"While inflammation is essential for us to fight bacterial and viral infections, too much inflammation can cause harm," says Dr. Miller. "There's always some collateral damage when the immune system gets fired up, and we now believe that too much inflammation, either at rest or during stress, may predispose people to become depressed or stay depressed." In addition, medical research over the last decade has shown that runaway inflammation may play a role in a number of disorders, including heart disease, cancer, and diabetes, all of which have been associated with depression.



People in the study who suffered from depression also had higher rates of early life stressful experiences. "We have found that this kind of personal life history may make people more likely to develop major depression and is actually common in depressed patients," says Dr. Heim.



It was part of a larger project at the Emory Conte Center for the Neuroscience of Mental Disorders led by Charles B. Nemeroff, MD, PhD, Reunette W. Harris Professor and Chair of Emory's Department of Psychiatry and Behavioral Sciences. The Conte Center is dedicated to understanding the contribution of early life abuse and neglect to the neurobiology of adulthood psychiatric disorders. Ongoing studies by Dr. Miller's team of researchers will attempt to determine how early life experiences contribute to excessive inflammatory stress responses.



"According to the Depression and Bipolar Support Alliance, major depression is the leading cause of disability worldwide and costs the U.S. economy $70 billion annually in medical expenditures, lost productivity, and other expenses," says Thaddeus Pace, PhD, lead author on the paper. "This study is leading us toward finding out what actually causes depression and to identifying what aspects of immune system function are abnormal in depressed people. The goal is to find potential targets within the molecular machinery of the immune system so we can better treat major depression and minimize its consequences on health."







The study was funded by the National Institute of Mental Health (NIMH) and the National Alliance for Research on Schizophrenia and Depression (NARSAD).



Other contributors to the study include Oyetunde Alagbe, MD, Tanja C. Mletzko, MS, and Dominique Musselman, MD, MS



Contact: Kathi Baker


Emory University Health Sciences Center

пятница, 3 июня 2011 г.

Bolder II study confirms therapeutic potential of 'Seroquel' in bipolar depression

Newly released top-line results from the Bolder II (BipOLar DEpRession) study have underlined the potential for 'Seroquel' (quetiapine fumarate) in the treatment of patients with major depressive episodes associated with bipolar disorder. In Bolder II, 'Seroquel' 300mg and 600mg doses achieved a statistically significant reduction in levels of bipolar depression compared with placebo (p







Bipolar disorder is a serious mental illness that affects approximately 3-4% of the adult population and is the sixth leading cause of disability in the world (3, 4, 5, 6). Patients with bipolar disorder are symptomatic almost half of their lives, and approximately two-thirds of that time is spent in the depressed phase of the illness (7). Currently 'Seroquel' is only approved for the treatment of mania associated with bipolar disorder.


"Bolder II shows that 'Seroquel' may provide substantial clinical benefits to patients with bipolar disorder", commented Carolyn Fitzsimons, Seroquel Commercial VP. "Based on prior discussions with the FDA and the results of Bolder II, AstraZeneca plans to file for a US licence extension for 'Seroquel' in the treatment of depressive episodes associated with bipolar disorder around the end of this year (2005)."


'Seroquel' has been licensed for the treatment of schizophrenia since 1997 and is available in 85 countries for the treatment of this condition. SEROQUEL is also licensed in 73 countries for the treatment of mania associated with bipolar disorder.


References:

1. BOLDER II study. AstraZeneca Data on File.

2. Calabrese JR et al. Am J Psychiatry 2005;162:1351-60.

3. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington DC, American Psychiatric Association, 2000:385;395.

4. Hirschfield et al. Screening for bipolar disorder in the community J Clin Psychiatry. 2003:64;53-59

5. Lish JD, Dime-Meenan S, Whybrow PC et al. The National Depressive and Manic-Depressive Association (DMDA) survey of bipolar members. J Affect Disord. 1994:31;281-294.

6. World Health Organization and the World Bank. The Global Burden of Disease: Summary. Cambridge, Mass: The Harvard School of Public Health Harvard University Press, 1996.

7. Judd, Lll, Akiskal, HS, Schettler, PJ, et al. The long-term natural history of the weekly symptomatic status of bipolar disorder. Arch Gen Psychiatry. 2002;59:530-537


'Seroquel' is a trademark of the AstraZeneca group of companies.


'Seroquel' is currently not licensed for the treatment of bipolar depression.


Bolder II was an eight week, multi-centre, placebo-controlled trial conducted in the US which evaluated the efficacy of 'Seroquel' (quetiapine) treatment at doses of 300 or 600mg in over 500 patients with bipolar disorder experiencing major depressive episodes. In Bolder, the primary endpoint for bipolar depression was change in baseline on the MADRS (Montgomery- Еsberg Depression Rating Scale). Bipolar depression and anxiety symptoms were assessed using the MADRS, HAM-D (Hamilton Rating Scale for Depression) and HAM-A (Hamilton Rating Scale for Anxiety Scale).


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 FTSE4Good 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'and 'Zomig'. 'Seroquel', which has proven efficacy and a very favourable side effect profile, is the fastest growing of the leading atypical antipsychotics and the number one prescribed atypical in the United States with global sales of $2 billion in 2004; 'Zomig' is a reliable migraine therapy and a leader within the triptan market.


astrazeneca


View drug information on Seroquel.

четверг, 2 июня 2011 г.

Optimism For Bipolar Disorder And Schizophrenia If Psychiatrists Abandon 19th Century Dogma, UK

Nineteenth century thinking about schizophrenia and bipolar disorder must be abandoned if psychiatry is to progress, said a leading UK psychiatrist. At a meeting of the Biochemical Society, Professor Nick Craddock from Cardiff University urged his profession to embrace the opportunities offered by new research methodologies.


Advanced technology and the large sample sizes in research have led to unprecedented advances in the identification of specific genetic risk factors for psychiatric disorders as recently as the last two years. "For more than 100 years there has been a widespread assumption that bipolar disorder (manic depression) and schizophrenia are completely separate diseases. Recent evidence, particularly from molecular genetics, shows the situation is not so simple. Some of the susceptibility genes are shared," he said.


Strong genetic associations have been reported in bipolar disorder and schizophrenia. Emerging data provide a powerful resource for exploring the relationship between psychiatric characteristics. "This new knowledge will help to explain why some people receive a diagnosis of schizophrenia at one time and bipolar disorder at another time and why some receive a mixed diagnosis - so called 'schizoaffective' disorder," he said.


It is already clear that, in general, genetic associations are not specific to one of the traditional diagnostic categories. For example, one gene variation (ZNF804A) is associated with risk of both bipolar disorder and schizophrenia, and some rare 'copy number' variations are associated with the risk of autism and epilepsy as well as schizophrenia. "There is an urgent need to think beyond diagnostic "boxes" and consider how variations in brain biology and function lead to the huge range of clinical variations seen in people with psychiatric diseases," said Professor Craddock.


Whilst many family and twin studies have demonstrated the importance of genetic factors influencing susceptibility to bipolar disorder, only recently have research technologies started to identify these risk factors. It is, according to Professor Craddock, a successful start to a long journey.


"We know that there are many genes involved in bipolar disorder. Two such genes have been strongly implicated in recent studies of over 10,000 individuals," he said. The action of both genes is thought to be through effects on the basic control of the excitability of nerve cells. Although not of immediate clinical use, this new understanding will open up new avenues for research and should ultimately lead to improved treatments.


Professor Craddock concluded, "This is a time of rapid progress in bipolar disorder research. Those with illness can be optimistic for the next generation."

Source
Biochemical Society

среда, 1 июня 2011 г.

Obesity Associated With Psychiatric Disorders, Decreased Odds Of Substance Abuse

Obesity is associated with a 25 percent increase in the risk of developing mood and anxiety disorders and a 25 percent decrease in likeliness for substance abuse, according to a paper in the July issue of Archives of General Psychiatry, one of the JAMA/Archives journals.



About 31 percent of all U.S. adults were obese in 2000, an increase from 23 percent in 1990, according to background information in the article. Obese adults are at higher risk of diabetes, cardiovascular disease and other harmful conditions. Previous studies have suggested a link between obesity and depression, but little research has examined the associations between obesity and other psychiatric disorders.



Gregory E. Simon, M.D., M.P.H., of the Group Health Cooperative, Seattle, and colleagues studied 9,125 adults from across the country who were interviewed as part of a large national survey of mental disorders between Feb. 5, 2001, and Feb. 12, 2003. Participants (average age 44.8 years) completed an in-home interview that included questions about demographic characteristics, height, weight and psychiatric disorders. These included mood disorders, such as major depression, dysthymia (persistent mild depression with associated symptoms) and bipolar disorder; anxiety disorders, such as panic disorder and generalized anxiety disorder; and substance abuse disorders, including alcohol or drug dependence.



Of all the participants, 6,795 had a body mass index (BMI) of less than 30 and 2,330 had a BMI of 30 or greater and were therefore considered obese. Those who were obese had a higher prevalence of mood and anxiety disorders and a lower prevalence of substance abuse disorders over their lifetimes. These associations remained similar for men and women. The link between obesity and mood disorders appeared strongest in non-Hispanic whites and in those with higher education levels.



"The estimated prevalence of lifetime mood disorder in those with BMIs below 30 and in those with BMIs 30 or higher translates to a population-attributable risk of 24 percent, which indicates that nearly one-quarter of the cases of obesity in the general population are attributable to the association with mood disorder," the authors write. "This calculation illustrates the public health importance of the association but does not indicate a direction for the causal relationship. It is equally correct to state that more than one-fifth of cases of mood disorder in the general population are attributable to the association with obesity." Increased appetite, weight gain, reduced physical activity and binge eating have all been associated with depression, potentially increasing risk for obesity. However, obesity could also contribute to depression by limiting physical activity, or through the stigma that may be associated with being overweight, especially among some women and other particular sociodemographic groups. An unknown third cause also could be linked to both. The results also do not indicate the mechanisms behind the negative association between obesity and substance abuse.



"We conclude that obesity is meaningfully associated with a range of common mood and anxiety disorders in the general U.S. population," the authors write. "Obesity is associated with a moderately lower risk of substance use disorder. Variation in the obesity-depression relationship by education level and race/ethnicity suggests an important role of social or cultural factors in mediating or moderating the relationship between obesity and mood disorders."







Editor's Note: Please see full study for complete funding information.



Contact: Joan DeClaire


JAMA and Archives Journals