NCT00097266
Completed
Phase 3
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country615 target enrollmentDecember 2004
ConditionsBipolar Disorder
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Bipolar Disorder
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 615
- Locations
- 1
- Primary Endpoint
- Change in a mania rating scale at endpoint
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
Exclusion Criteria
- Not provided
Arms & Interventions
A
Intervention: Placebo
B
Intervention: Aripiprazole
C
Intervention: Haloperidol
Outcomes
Primary Outcomes
Change in a mania rating scale at endpoint
Secondary Outcomes
- Response rate and Clinical Global Impression scale at endpoint
Study Sites (1)
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