Major Depressive Disorder Clinical Trial
Official title:
A Study of Adjunctive Aripiprazole in 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 | December 2006 |
Est. primary completion date | December 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 | Albuquerque | New Mexico |
United States | Local Institution | Arlington | Virginia |
United States | Local Institution | Atlanta | Georgia |
United States | Local Institution | Bellevue | Washington |
United States | Local Institution | Beverly Hills | California |
United States | Local Institution | Brooklyn | New York |
United States | Local Institution | Brown Deer | Wisconsin |
United States | Local Institution | Burbank | California |
United States | Local Institution | Cincinnati | Ohio |
United States | Local Institution | Dallas | Texas |
United States | Local Institution | Denver | Colorado |
United States | Local Institution | Farmington | Connecticut |
United States | Local Institution | Herndon | Virginia |
United States | Local Institution | Houston | Texas |
United States | Local Institution | Jacksonville | Florida |
United States | Local Institution | Memphis | Tennessee |
United States | Local Institution | Middleton | Wisconsin |
United States | Local Institution | National City | California |
United States | Local Institution | New York | New York |
United States | Local Institution | Orange | California |
United States | Local Institution | Orlando | Florida |
United States | Local Institution | Pasadena | California |
United States | Local Institution | Pittsburgh | Pennsylvania |
United States | Local Institution | Portland | Oregon |
United States | Local Institution | Richmond | Virginia |
United States | Local Institution | Rockville | Maryland |
United States | Local Institution | Seattle | Washington |
United States | Local Institution | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Otsuka America Pharmaceutical |
United States,
Fava M, Wisniewski SR, Thase ME, Baker RA, Tran QV, Pikalov A, Yang H, Marcus RN, Berman RM. Metabolic assessment of aripiprazole as adjunctive therapy in major depressive disorder: a pooled analysis of 2 studies. J Clin Psychopharmacol. 2009 Aug;29(4):362-7. doi: 10.1097/JCP.0b013e3181ac9b0b. — View Citation
Marcus RN, McQuade RD, Carson WH, Hennicken D, Fava M, Simon JS, Trivedi MH, Thase ME, Berman RM. The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol. 2008 Apr;28(2):156-65. doi: 10.1097/JCP.0b013e31816774f9. — View Citation
Nelson JC, Thase ME, Trivedi MH, Fava M, Han J, Van Tran Q, Pikalov A, Qi Y, Carlson BX, Marcus RN, Berman RM. Safety and Tolerability of Adjunctive Aripiprazole in Major Depressive Disorder: A Pooled Post Hoc Analysis (studies CN138-139 and CN138-163). Prim Care Companion J Clin Psychiatry. 2009;11(6):344-52. doi: 10.4088/PCC.08m00744gre. — View Citation
Thase ME, Trivedi MH, Nelson JC, Fava M, Swanink R, Tran QV, Pikalov A, Yang H, Carlson BX, Marcus RN, Berman RM. Examining the efficacy of adjunctive aripiprazole in major depressive disorder: a pooled analysis of 2 studies. Prim Care Companion J Clin Psychiatry. 2008;10(6):440-7. — View Citation
Trivedi MH, Thase ME, Fava M, Nelson CJ, Yang H, Qi Y, Tran QV, Pikalov A, Carlson BX, Marcus RN, Berman RM. Adjunctive aripiprazole in major depressive disorder: analysis of efficacy and safety in patients with anxious and atypical features. J Clin Psychiatry. 2008 Dec;69(12):1928-36. Epub 2008 Dec 2. — View Citation
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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