Trials / Completed
CompletedNCT00105196
A Study of Aripiprazole in Patients With Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 349 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aripiprazole+ ADT | Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks |
| DRUG | Placebo+ ADT | Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks |
Timeline
- Start date
- 2005-03-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2005-03-10
- Last updated
- 2013-12-02
- Results posted
- 2009-05-18
Locations
34 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00105196. Inclusion in this directory is not an endorsement.