Trials / Completed
CompletedNCT00257972
Study of Aripiprazole in Patients With Bipolar I Disorder
Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (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 compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aripiprazole |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2005-11-24
- Last updated
- 2013-11-08
Locations
90 sites across 17 countries: United States, Australia, Bulgaria, Czechia, Estonia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russia, South Africa, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00257972. Inclusion in this directory is not an endorsement.