A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095758
• Other study ID #: CN138-163
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2004
• Last updated: November 22, 2013
• Start date: September 2004
• Est. completion date: December 2006

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• Antidepressant + Aripiprazole
Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm