A multicenter, investigative study of the safety and efficacy of extended administration of aripiprazole in combination with mood stabilizer for 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-jRCT2080220515
- 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-Subjects who were enrolled in and have completed or withdrawn from Study 003 and who meet the following criteria
Subjects who show exacerbation of condition or no change in condition:
Those subjects who completed Study 003, and whose score for CGI-BP Change from preceding phase (mania) on Day 21 (completion of Study 003) was between 5 (Minimally worse) and 7 (Very much worse) (subjects showing exacerbation of condition), or whose score was 4 (No change) (subjects showing no change in condition)
Subjects who discontinued due to lack of drug efficacy:
Those subjects who discontinued Study 003 between Day 14 and Day 21, for whom the reason of withdrawal was lack of drug efficacy, and whose score for CGI-BP Change from preceding phase (mania) was between 5 (Minimally worse) and 7 (Very much worse)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method