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.
понедельник, 20 июня 2011 г.
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
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
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.
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
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
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
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
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