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A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00095758
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
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

Study Type : Interventional  (Clinical Trial)
Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
Study Start Date : September 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

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



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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00095758


  Show 28 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00095758     History of Changes
Other Study ID Numbers: CN138-163
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Aripiprazole
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs