Trials / Completed
CompletedNCT00261443
A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,270 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lithium or Valproate with placebo (PBO) | Tablets, Oral, once daily lithium 250-2100 mg/day valproate 250-2500mg/day Placebo once daily |
| DRUG | Lithium or Valproate with Aripiprazole | Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks) lithium 250-2100 mg/day valproate 250-2500mg/day aripiprazole 15-30 mg/day |
Timeline
- Start date
- 2005-09-01
- Primary completion
- 2009-06-01
- Completion
- 2009-10-01
- First posted
- 2005-12-05
- Last updated
- 2023-04-18
- Results posted
- 2011-04-27
Locations
83 sites across 9 countries: United States, Brazil, Bulgaria, Croatia, Czechia, France, India, Russia, South Africa
Source: ClinicalTrials.gov record NCT00261443. Inclusion in this directory is not an endorsement.