Trials / Completed
CompletedNCT00097266
Study of Aripiprazole in Patients With Acute Bipolar Mania
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 615 (planned)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks). |
| DRUG | Aripiprazole | Tablets, oral, 15-30 mg, once daily, 12 weeks. |
| DRUG | Haloperidol | Capsule, oral, 5-15 mg, once daily, 12 weeks. |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2007-01-01
- Completion
- 2007-01-01
- First posted
- 2004-11-22
- Last updated
- 2013-11-08
Locations
45 sites across 7 countries: United States, Bulgaria, Croatia, Mexico, Peru, Russia, South Africa
Source: ClinicalTrials.gov record NCT00097266. Inclusion in this directory is not an endorsement.