A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder.

Bristol-Myers Squibb1 site in 1 country1,200 target enrollmentJune 2004

ConditionsMajor Depressive Disorder

InterventionsAntidepressant + Placebo Antidepressant + Aripiprazole

DrugsAntidepressant + Placebo Antidepressant + Aripiprazole

Overview

Phase: Phase 3
Intervention: Antidepressant + Placebo
Conditions: Major Depressive Disorder
Sponsor: Bristol-Myers Squibb
Enrollment: 1200
Locations: 1
Primary Endpoint: Change in a depression rating scale at endpoint
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

August 2006

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

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.