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A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00095823
First received: November 9, 2004
Last updated: November 22, 2013
Last verified: November 2013

November 9, 2004
November 22, 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
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00095823
CN138-139
Not Provided
Not Provided
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