Clinical trial NCT00095823: A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-11-09
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in a depression rating scale at endpoint
Secondary outcomes:
measure: Change in a disability scale and Clinical Global Impression scale at endpoint
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Local Institution
state: California
city: Northridge
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Edwardsville
country: United States
facility: Local Institution
state: Illinois
city: Rockville
country: United States
facility: Local Institution
state: Maryland
city: Springfield
country: United States
facility: Local Institution
state: Massachusetts
city: Farmington Hills
country: United States
facility: Local Institution
state: Michigan
city: Okemos
country: United States
facility: Local Institution
state: Michigan
city: Staten Island
country: United States
facility: Local Institution
state: New York
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
city: Woodstock
country: United States
facility: Local Institution
state: Vermont
city: Charlottesville
country: United States
facility: Local Institution
state: Virginia
city: Bellevue
country: United States
facility: Local Institution
state: Washington
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: Middleton
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Stewart TD, Hatch A, Largay K, Sheehan JJ, Marler SV, Berman RM, Nelson JC. Effect of symptom severity on efficacy and safety of aripiprazole adjunctive to antidepressant monotherapy in major depressive disorder: a pooled analysis. J Affect Disord. 2014 Jun;162:20-5. doi: 10.1016/j.jad.2014.03.017. Epub 2014 Mar 24.
citation: Casey DE, Laubmeier KK, Marler SV, Forbes RA, Baker RA. Efficacy of adjunctive aripiprazole in major depressive disorder: a pooled response quartile analysis and the predictive value of week 2 early response. Prim Care Companion CNS Disord. 2012;14(3):PCC.11m01251. doi: 10.4088/PCC.11m01251. Epub 2012 May 31.
citation: Fabian TJ, Cain ZJ, Ammerman D, Eudicone JM, Tang Y, Rollin LM, Forbes RA, Berman RM, Baker RA. Improvement in functional outcomes with adjunctive aripiprazole versus placebo in major depressive disorder: a pooled post hoc analysis of 3 short-term studies. Prim Care Companion CNS Disord. 2012;14(6):PCC.12m01394. doi: 10.4088/PCC.12m01394. Epub 2012 Dec 20.
citation: Dunner DL, Laubmeier KK, Manos G, Forbes RA, Baker RA, Berman RM. Beneficial effects of adjunctive aripiprazole in major depressive disorder are not dependent on antidepressant therapy history: a post hoc analysis of 3 randomized, double-blind, placebo-controlled trials. Prim Care Companion CNS Disord. 2012;14(6):PCC.12m01380. doi: 10.4088/PCC.12m01380. Epub 2012 Nov 22.
citation: Fava M, Dording CM, Baker RA, Mankoski R, Tran QV, Forbes RA, Eudicone JM, Owen R, Berman RM. Effects of adjunctive aripiprazole on sexual functioning in patients with major depressive disorder and an inadequate response to standard antidepressant monotherapy: a post hoc analysis of 3 randomized, double-blind, placebo-controlled studies. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m00994. doi: 10.4088/PCC.10m00994gre.
citation: Weisler RH, Khan A, Trivedi MH, Yang H, Eudicone JM, Pikalov A, Tran QV, Berman RM, Carlson BX. Analysis of suicidality in pooled data from 2 double-blind, placebo-controlled aripiprazole adjunctive therapy trials in major depressive disorder. J Clin Psychiatry. 2011 Apr;72(4):548-55. doi: 10.4088/JCP.09m05495gre. Epub 2010 Aug 24.
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.
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.
citation: Boulton DW, Balch AH, Royzman K, Patel CG, Berman RM, Mallikaarjun S, Reeves RA. The pharmacokinetics of standard antidepressants with aripiprazole as adjunctive therapy: studies in healthy subjects and in patients with major depressive disorder. J Psychopharmacol. 2010 Apr;24(4):537-46. doi: 10.1177/0269881108096522. Epub 2008 Oct 2.
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. doi: 10.4088/pcc.v10n0603.
citation: Berman RM, Marcus RN, Swanink R, McQuade RD, Carson WH, Corey-Lisle PK, Khan A. The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2007 Jun;68(6):843-53. doi: 10.4088/jcp.v68n0604.