A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Antidepressant + Placebo; Drug: Antidepressant + Aripiprazole

• 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

Study Timeline

• Study Start: 2004-09
• Study First Submitted QC: 2004-11-08
• Study First Submitted: 2004-11-09
• Study First Posted: 2004-11-09
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-22
• Last Update Posted: 2013-11-25

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