Trials / Completed
CompletedNCT00094432
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive 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. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 650 (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 several doses of aripiprazole 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
- 2004-06-01
- Primary completion
- 2006-11-01
- Completion
- 2006-11-01
- First posted
- 2004-10-19
- Last updated
- 2013-11-11
Locations
40 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00094432. Inclusion in this directory is not an endorsement.