A multicenter investigative study of the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer for the treatment of patients with bipolar disorder experiencing a manic or mixed episode
Phase 3
- Conditions
- Acute manic and mixed episodes associated with Bipolar I Disorder
- Registration Number
- JPRN-jRCT2080220516
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
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.
-Patients 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
-Patients with a YMRS total score of 16 or more
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method