COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 1 for:    NCT00095823
Previous Study | Return to List | Next Study

A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00095823
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : November 25, 2013
Otsuka America Pharmaceutical
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Antidepressant + Placebo Drug: Antidepressant + Aripiprazole Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : June 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Placebo Comparator: A1 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.

Active Comparator: A2 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.
Other Name: Abilify

No Intervention: A3

Primary Outcome Measures :
  1. Change in a depression rating scale at endpoint

Secondary Outcome Measures :
  1. Change in a disability scale and Clinical Global Impression scale at endpoint

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00095823

Layout table for location information
United States, California
Local Institution
Garden Grove, California, United States
Local Institution
Northridge, California, United States
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Florida
Local Institution
Jacksonville, Florida, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
Local Institution
Edwardsville, Illinois, United States
United States, Maryland
Local Institution
Rockville, Maryland, United States
United States, Massachusetts
Local Institution
Springfield, Massachusetts, United States
United States, Michigan
Local Institution
Farmington Hills, Michigan, United States
Local Institution
Okemos, Michigan, United States
United States, New York
Local Institution
Staten Island, New York, United States
United States, Oregon
Local Institution
Portland, Oregon, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
United States, Texas
Local Institution
Austin, Texas, United States
United States, Utah
Local Institution
Salt Lake City, Utah, United States
United States, Vermont
Local Institution
Woodstock, Vermont, United States
United States, Virginia
Local Institution
Charlottesville, Virginia, United States
United States, Washington
Local Institution
Bellevue, Washington, United States
Local Institution
Seattle, Washington, United States
United States, Wisconsin
Local Institution
Middleton, Wisconsin, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00095823    
Other Study ID Numbers: CN138-139
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists