Clinical trial NCT00105196: A Study of Aripiprazole in Patients With Major Depressive Disorder
Official title: A Study of Aripiprazole in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Single or recurrent
non-psychotic episode of Major Depressive Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2005-03-10
Enrollment: 349
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: DIAGNOSTIC

Brief summary: The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of 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 adequate antidepressant trials.

Primary outcomes:
measure: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)
timeFrame: Baseline (Week 8) and Week 14
Secondary outcomes:
measure: Mean Change in Sheehan Disability Scale (SDS) Mean Score
timeFrame: Baseline (Week 8) and Week 14
measure: Mean Change in SDS Item Score (Social Life)
timeFrame: Baseline (Week 8) and Week 14
measure: Mean Change in SDS Item Score (Family Life)
timeFrame: Baseline (Week 8) and Week 14
measure: Mean Change in SDS Item Score (Work/School)
timeFrame: Baseline (Week 8) and Week 14
Other outcomes:
measure: MADRS Response
timeFrame: Baseline (Week 8) and Week 14
measure: Clinical Global Impression (CGI)-Improvement Response
timeFrame: Baseline (Week 8) and Week 14
measure: MADRS Remission
timeFrame: Baseline (Week 8) and Week 14
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Coral Springs
country: United States
facility: Cns Clinical Research Group
state: Florida
city: Augusta
country: United States
facility: Medical College Of Georgia
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute, Llc
state: Illinois
city: Edwardsville
country: United States
facility: Cunningham Clinical Research, Llc
state: Illinois
city: Hoffman Estates
country: United States
facility: Comprehensive Neuroscience, Inc.
state: Illinois
city: Springfield
country: United States
facility: Vine Street Clinical Research Center
state: Illinois
city: Witchita
country: United States
facility: Clinical Research Institute
state: Kansas
city: New Orleans
country: United States
facility: Lsu Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Farmington Hills
country: United States
facility: Summit Research Network
state: Michigan
city: Flint
country: United States
facility: Summit Research Network
state: Michigan
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: St. Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Las Vegas
country: United States
facility: Radiant Research Las Vegas
state: Nevada
city: Charlotte
country: United States
facility: Behavioral Health Center
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Phebe Tucker, Md
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Southeast Health Consultants
state: South Carolina
city: Columbia
country: United States
facility: Usc School Of Medicine
state: South Carolina
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research, Slc
state: Utah
city: Salt Lake City
country: United States
facility: University Of Utah School Of Medicine
state: Utah
city: Charlottesville
country: United States
facility: University Of Virginia
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Brown Deer
country: United States
facility: Northbrooke Research Center
state: Wisconsin
city: Middleton
country: United States
facility: Dean Foundation For Health Research & Education
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Berman RM, Fava M, Thase ME, Trivedi MH, Swanink R, McQuade RD, Carson WH, Adson D, Taylor L, Hazel J, Marcus RN. Aripiprazole augmentation in major depressive disorder: a double-blind, placebo-controlled study in patients with inadequate response to antidepressants. CNS Spectr. 2009 Apr;14(4):197-206. doi: 10.1017/s1092852900020216.
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.