NCT00095511
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.2 sites in 1 country615 target enrollmentJune 2004
ConditionsBipolar Disorder
Drugsaripiprazole
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 615
- Locations
- 2
- Primary Endpoint
- Change from baseline to endpoint in a mania rating scale
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this trial is to test the safety & efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary diagnosis of Acute Bipolar I Mania
Exclusion Criteria
- •Patients with a DSM-IV diagnosis other than Bipolar I Mania
Outcomes
Primary Outcomes
Change from baseline to endpoint in a mania rating scale
Secondary Outcomes
- Response rate and Clinical Global Impression scale at endpoint
Study Sites (2)
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