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A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00095823
First Posted: November 9, 2004
Last Update Posted: November 25, 2013
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.
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
November 9, 2004
November 9, 2004
November 25, 2013
June 2004
August 2006   (Final data collection date for primary outcome measure)
Change in a depression rating scale at endpoint
Not Provided
Complete list of historical versions of study NCT00095823 on ClinicalTrials.gov Archive Site
Change in a disability scale and Clinical Global Impression scale at endpoint
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A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • 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.
  • 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
  • Placebo Comparator: A1
    Intervention: Drug: Antidepressant + Placebo
  • Active Comparator: A2
    Intervention: Drug: Antidepressant + Aripiprazole
  • No Intervention: A3

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
August 2006
August 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00095823
CN138-139
Not Provided
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Bristol-Myers Squibb
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP