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COMPLETED
NCT00095823
PHASE3

A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2004-06

Completion Date

2006-08

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

Antidepressant + Placebo

Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.

DRUG

Antidepressant + Aripiprazole

Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.

Locations (20)

Local Institution

Garden Grove, California, United States

Local Institution

Northridge, California, United States

Local Institution

Washington D.C., District of Columbia, United States

Local Institution

Jacksonville, Florida, United States

Local Institution

Chicago, Illinois, United States

Local Institution

Edwardsville, Illinois, United States

Local Institution

Rockville, Maryland, United States

Local Institution

Springfield, Massachusetts, United States

Local Institution

Farmington Hills, Michigan, United States

Local Institution

Okemos, Michigan, United States

Local Institution

Staten Island, New York, United States

Local Institution

Portland, Oregon, United States

Local Institution

Philadelphia, Pennsylvania, United States

Local Institution

Austin, Texas, United States

Local Institution

Salt Lake City, Utah, United States

Local Institution

Woodstock, Vermont, United States

Local Institution

Charlottesville, Virginia, United States

Local Institution

Bellevue, Washington, United States

Local Institution

Seattle, Washington, United States

Local Institution

Middleton, Wisconsin, United States