A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Antidepressant + Placebo
- Registration Number
- NCT00095758
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
Inclusion Criteria
- Men and women, 18-65 years old
- Experienced a Major Depressive Disorder with the current episode of minimally 8 weeks in duration.
- Treatment history of an inadequate response to at least one and no more than three antidepressants.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 Antidepressant + Placebo - A2 Antidepressant + Aripiprazole -
- Primary Outcome Measures
Name Time Method Change in a depression rating scale at endpoint
- Secondary Outcome Measures
Name Time Method Change in a disability scale and Clinical Global Impression scale at endpoint
Trial Locations
- Locations (1)
Local Institution
🇺🇸Middleton, Wisconsin, United States