A Study of Aripiprazole in Patients With Major Depressive Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.

Key facts

Study ID

NCT00105196

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

349

Starts

2005-03-01

Expected to finish

2008-03-01

Last updated by the study team

2013-12-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of 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 adequate antidepressant trials.

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Cns Clinical Research Group — Coral Springs, Florida, United States
• Medical College Of Georgia — Augusta, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Uptown Research Institute, Llc — Chicago, Illinois, United States
• Cunningham Clinical Research, Llc — Edwardsville, Illinois, United States
• Comprehensive Neuroscience, Inc. — Hoffman Estates, Illinois, United States
• Vine Street Clinical Research Center — Springfield, Illinois, United States
• Clinical Research Institute — Witchita, Kansas, United States
• Lsu Health Sciences Center — New Orleans, Louisiana, United States
• Pharmasite Research, Inc. — Baltimore, Maryland, United States
• Summit Research Network — Farmington Hills, Michigan, United States
• Summit Research Network — Flint, Michigan, United States
• University Of Minnesota — Minneapolis, Minnesota, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• Radiant Research Las Vegas — Las Vegas, Nevada, United States
• Behavioral Health Center — Charlotte, North Carolina, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Phebe Tucker, Md — Oklahoma City, Oklahoma, United States
• Summit Research Network — Portland, Oregon, United States
• Suburban Research Associates — Media, Pennsylvania, United States
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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