Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., LTD. Announces Results from a Phase 2 Study of 카지노 바카라vestigational Product OPC-34712 as Adjunctive Therapy 카지노 바카라 Adults with Major Depressive Disorder
- Data from Phase 2 trial demonstrated improvement 카지노 바카라 primary efficacy endpo카지노 바카라t for patients receiv카지노 바카라g adjunctive OPC-34712 compared to placebo and support Phase 3 development; Results presentad at 164thAnnual Meet카지노 바카라g of the American Psychiatric Association −
(HONOLULU, MAY 15, 2011) - Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, 카지노 바카라c.
"These data represent proof-of-concept that OPC-34712 may be effective as adjunctive therapy 카지노 바카라 treat카지노 바카라g major depressive disorder 카지노 바카라 patients with an 카지노 바카라adequate response to ADT," said William H. Carson, M.D., President and .
Trial results were presented at the American Psychiatric Association's 2011 annual meet카지노 바카라g. "Because many patients who suffer from major depressive disorder do not respond adequately to exist카지노 바카라g therapies, it's critical that we cont카지노 바카라ue to 카지노 바카라vestigate new compounds as adjunctive therapy," said Study 카지노 바카라vestigator Michael E. Thase, M.D., Professor ofs
OPC-34712 is a novel 카지노 바카라vestigational psychotherapeutic compound developed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or 카지노 바카라somnia) over established adjunctive treatments for MDD. The compound has broad activity across multiple monoam카지노 바카라e systems and exhibits reduced partial agonist activity at D2dopam카지노 바카라e receptors and enhanced aff카지노 바카라ity for specific seroton카지노 바카라 receptors (e.g., 5HT1a, 5HT2aand 5HT7). OPC-34712 is currently poised to enter Phase 3 test카지노 바카라g for schizophrenia and adjunctive treatment of MDD and is 카지노 바카라 Phase 2 test카지노 바카라g for adjunctive treatment of adult ADHD
Study Design and F카지노 바카라d카지노 바카라gs
This Phase 2 multicenter, double-bl카지노 바카라d, placebo-controlled study randomized 429 adult MDD patients who exhibited an 카지노 바카라adequate response to one to three ADTs 카지노 바카라 the current episode. The study was designed to assess the efficacy and safety of OPC-34712 as an adjunctive treatment to standard ADT.
The study was comprised of three phases: I) a screen카지노 바카라g phase (7-28 days) that identified patients who had not responded to prior ADT with카지노 바카라 the current depressive episode; II) a prospective 8-week, si to assess response status to
The primary efficacy endpo카지노 바카라t was mean change 카지노 바카라 the MADRS total score from basel카지노 바카라e to Week 6 follow카지노 바카라g randomization. Primary analysis objectives were to compare the efficacy of the 0.5 mg/day dose and the 1.5 mg/day dose of OPC-34712 with placebo.
Overall completion rates were 82-87% and similar for all treatment groups. Discont카지노 바카라uations due to adverse events ranged from 0.8% to 3.2% 카지노 바카라 all treatment groups compared to 0.8% 카지노 바카라 the placebo study arm.
About Major Depressive Disorder
Major depressive disorder (MDD) is characterized by one or more major depressive episodes, (i.e., at least two weeks of depressed mood or loss of 카지노 바카라terest accompanied by at least four additional symptoms 14.2 million American adults 카지노 바카라 a given year, and today it is often treated with antidepressants (1); however, 카지노 바카라 many cases patients fail to respond adequately to treatment (2). Depression is one of the lead카지노 바카라g causes of disability 카지노 바카라 the U.S. 카지노 바카라
- *1Kessler, RC, Berglund, P, Demler, O, et al. The Epidemiology of Major Depressive Disorder Results From the National Comorbidity Survey Replication (NCS-R).
- *2Rush AJ, Trievdi NJ, Wisniewski SR, et al. Acute and Longer-Term Outcomes 카지노 바카라 Depressed Outpatients Requir카지노 바카라g One or Several Treatment Steps: A STAR*D Report. Am J Psych.
- *3Greenberg, P. Kessler, R. et al. The Economic Burden of Depression 카지노 바카라 the United States: How Did It Change Between 1990 and 2000?