A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder

Phase 3

Completed

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

• Registration Number: NCT00095745
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.

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: 2007-11
• Study Completion: 2007-11
• Status Verified: 2011-04
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1002

Inclusion Criteria

• Men and women, 18 years or older
• Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
• Treatment history of an inadequate response to at least one and no more than four antidepressants

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antidepressant + Aripiprazole	Antidepressant + Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
Safety assessments	throughout the study

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Middleton, Wisconsin, United States