JPRN-jRCT2080220516
Unknown
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute manic and mixed episodes associated with Bipolar I Disorder
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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