A multicenter, placebo-controlled, double-blind, investigative extension trial of the safety and efficacy of aripiprazole in the treatment of patients with bipolar disorder experiencing a manic or mixed episode
- Conditions
- Acute manic and mixed episodes associated with Bipolar I Disorder
- Registration Number
- JPRN-jRCT2080220514
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
-Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having 296.4x Bipolar I Disorder in which the most recent episode was manic or 296.6x Bipolar I Disorder in which the most recent episode was mixed
-Subjects who were enrolled in and have completed Study 003 and who meet the following criteria for demonstration of drug efficacy
Subjects demonstrating drug efficacy:
Those subjects who completed Study 003 whose score for CGI-BP Change From Preceding Phase (mania) at the time of evaluation on Day 21 of Study 003 (completion) was between 1 (Very much improved) and 3 (Minimally improved)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method