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
ClinicalTrials.gov 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 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.

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: June 2004
Study Completion Date: August 2006
Primary Completion Date: August 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
No Intervention: A3


Ages Eligible for Study:   18 Years to 65 Years
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 ClinicalTrials.gov identifier: NCT00095823

  Show 20 Study Locations
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 ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00095823     History of Changes
Other Study ID Numbers: CN138-139 
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
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 02, 2016