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A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

This study has been completed.
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb Identifier:
First received: November 9, 2004
Last updated: November 22, 2013
Last verified: November 2013
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 Intervention Phase
Major Depressive Disorder
Drug: Antidepressant + Placebo
Drug: Antidepressant + Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

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

Estimated Enrollment: 1200
Study Start Date: September 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00095758

  Hide Study Locations
United States, California
Local Institution
Beverly Hills, California, United States
Local Institution
Burbank, California, United States
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National City, California, United States
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Orange, California, United States
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Pasadena, California, United States
United States, Colorado
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Denver, Colorado, United States
United States, Connecticut
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Farmington, Connecticut, United States
United States, Florida
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Jacksonville, Florida, United States
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Orlando, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
United States, Maryland
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Rockville, Maryland, United States
United States, New Mexico
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Albuquerque, New Mexico, United States
United States, New York
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Brooklyn, New York, United States
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New York, New York, United States
United States, Ohio
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
United States, Oregon
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Portland, Oregon, United States
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States
United States, Tennessee
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Memphis, Tennessee, United States
United States, Texas
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Dallas, Texas, United States
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Houston, Texas, United States
United States, Virginia
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Arlington, Virginia, United States
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Herndon, Virginia, United States
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Richmond, Virginia, United States
United States, Washington
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Bellevue, Washington, United States
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Seattle, Washington, United States
United States, Wisconsin
Local Institution
Brown Deer, Wisconsin, United States
Local Institution
Middleton, Wisconsin, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00095758     History of Changes
Other Study ID Numbers: CN138-163 
Study First Received: November 9, 2004
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on October 21, 2016