NCT00094432
Completed
Phase 3
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.
Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country650 target enrollmentJune 2004
Overview
- Phase
- Phase 3
- Intervention
- Aripiprazole
- Conditions
- Bipolar I Disorder
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 650
- Locations
- 1
- Primary Endpoint
- Mean change from baseline to endpoint on the MADRS total score.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women, ages 18-65
- •Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.
Exclusion Criteria
- Not provided
Arms & Interventions
A1
Intervention: Aripiprazole
A2
Intervention: Placebo
Outcomes
Primary Outcomes
Mean change from baseline to endpoint on the MADRS total score.
Secondary Outcomes
- Clinical Global Impression - Bipolar Version
- Severity of illness score depression
- Mean change from baseline to endpoint
Study Sites (1)
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