Major Depressive Disorder Clinical Trial
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.
Verified date | November 2013 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1200 |
Est. completion date | August 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Local Institution | Austin | Texas |
United States | Local Institution | Bellevue | Washington |
United States | Local Institution | Charlottesville | Virginia |
United States | Local Institution | Chicago | Illinois |
United States | Local Institution | Edwardsville | Illinois |
United States | Local Institution | Farmington Hills | Michigan |
United States | Local Institution | Garden Grove | California |
United States | Local Institution | Jacksonville | Florida |
United States | Local Institution | Middleton | Wisconsin |
United States | Local Institution | Northridge | California |
United States | Local Institution | Okemos | Michigan |
United States | Local Institution | Philadelphia | Pennsylvania |
United States | Local Institution | Portland | Oregon |
United States | Local Institution | Rockville | Maryland |
United States | Local Institution | Salt Lake City | Utah |
United States | Local Institution | Seattle | Washington |
United States | Local Institution | Springfield | Massachusetts |
United States | Local Institution | Staten Island | New York |
United States | Local Institution | Washington | District of Columbia |
United States | Local Institution | Woodstock | Vermont |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Otsuka America Pharmaceutical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in a depression rating scale at endpoint | |||
Secondary | Change in a disability scale and Clinical Global Impression scale at endpoint |
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