Forest Laboratories, Inc. And Gedeon Richter Plc Announce Results From A Phase II Study Of Cariprazine For The Treatment Of Bipolar Depression
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of bipolar depression. Cariprazine is currently undergoing Phase III trials for separate indications of schizophrenia and bipolar mania. A total of 233 patients were randomized to enter one of two active (low dose or high dose) treatment arms or placebo. The primary endpoint was the Montgomery Asberg Depression Rating Scale (MADRS) score. The study was designed to be exploratory. Although the overall difference observed between the drug-treated and placebo-treated groups was not statistically significant, over the course of the trial there was evidence of a clinically relevant treatment effect in the high-dose arm of the study by comparison to placebo.
The National Alliance on Mental Illness (NAMI) is providing a new dimension to its Hearts & Minds initiative, an educational program that promotes "mind and body" health practices for individuals who live with mental illness. A new "Mindfulness" section on NAMI's Hearts and Minds website includes a 10-minute video of guided mediation, along with information about other holistic methods to complement medication and therapy and help a person to gain greater control over the recovery process. Practices covered include basic meditation, guided imagery, yoga and Tai Chi, and creative outlets such as writing, art, music and dance. Ed Knight of Â says he uses meditation to help control hearing voices and panic attacks: "Without the combination of meditation and medication, I would be in and out of the hospital very frequently.
MSD Receives European Approval Of Its Atypical Antipsychotic Medication SYCREST R For The Treatment Of Manic Episodes In Bipolar I Disorder
MSD (MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A). announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States. "Bipolar I disorder is difficult to manage, and patients frequently discontinue therapy for a variety of reasons, " said Eduard Vieta, M.D., Ph.D., professor of psychiatry at the University of Barcelona, and director of the Bipolar Disorders Program of the Hospital Clinic, Barcelona, Spain.
Patients with bipolar disorder may be eligible for a new clinical research study comparing two medications -- quetiapine ( Seroquel ), a widely prescribed second-generation antipsychotic mood-stabilizing medication, and lithium, the gold-standard mood stabilizer. NewYork-Presbyterian Hospital/Weill Cornell Medical Center is one of 10 sites nationally -- and the only site in the greater New York metropolitan area -- participating in the CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness) study. The research is funded by a $10 million grant from the U.S. Agency for Healthcare Research Quality (AHRQ). "Antipsychotic drugs have long been known to be useful for the treatment of bipolar disorder, but neurological side effects and toxicity have limited their long-term use.
A new study from Sweden's Karolinska Institutet suggests that bipolar disorder - or manic-depressive disorder - does not increase the risk of committing violent crime. Instead, the over-representation of individuals with bipolar disorder in violent crime statistics is almost entirely attributable to concurrent substance abuse. The public debate on violent crime usually assumes that violence in the mentally ill is a direct result of the perpetrator's illness. Previous research has also suggested that patients with bipolar disorder - also known as manic-depressive disorder - are more likely to behave violently. However, it has been unclear if the violence is due to the bipolar disorder per se, or caused by other aspects of the individual's personality or lifestyle. The new study, carried out by researchers at Karolinska Institutet and Oxford University, is presented in the scientific journal Archives of General Psychiatry.