A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared with Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes Associated with Bipolar I Disorder - Protocol R076477-BIM-3002 Phase 3
- Conditions
- Bipolar I Disorder
- Registration Number
- EUCTR2005-005812-25-LT
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 475
Man or woman between 18 (or the minimum age to provide informed consent in the jurisdiction in which the study is taking place, whichever is older) and 65 years of age; Meet DSM-IV criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features) at the time of screening; History of at least 1 previoulsy documented manic or mixed episode requiring medical treatment within the 3 years before screening phase
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Unable to provide their own consent; Meet DSM-IV criteria other than Bipolar I Disorder; Meet DSM-IV criteria for rapid cycling and schizoaffective disorder; use of clozapine, aripiprazole, or fluoxetine within 1 month before the screening phase; Alcohol intoxication within 3 days before study drug administration on Day 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives of the study are to demonstrate the antimanic efficacy and to assess the safety of flexibly dosed paliperidone extended release (ER) compared with placebo during 3 weeks of treatment in subjects with Bipolar I Disorder who are experiencing an acute manic or mixed episode;Secondary Objective: To demonstrate that flexibly dosed paliperidone ER and quetiapine have comparable antimanic efficacy over a 12 week period; to assess the safety of flexibly dosed paliperidone ER over a 12 week period; and to assess the effect on global functioning associated with flexibly dosed paliperidone ER compared with placebo over a 3 week period;Primary end point(s): Efficacy assessments include the YMRS, GAF, CGI-BP-S, PANSS, VAS and the SF-36. The primary efficacy endpoint for this study is the change from baseline in total YMRS score at the end of the double blind, acute treatment phase
- Secondary Outcome Measures
Name Time Method