Trials / Completed
CompletedNCT00080314
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (planned)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aripiprazole | Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks. |
| DRUG | Placebo | Tablets, Oral, 0 mg, Once daily, 8 weeks. |
Timeline
- Start date
- 2004-01-01
- Primary completion
- 2006-10-01
- Completion
- 2006-10-01
- First posted
- 2004-03-30
- Last updated
- 2013-11-11
Locations
28 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00080314. Inclusion in this directory is not an endorsement.