Back to resultsA Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Antidepressant + Placebo
Antidepressant + Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- Local Institution
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- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
A1
A2
Arm Description
Outcomes
Primary Outcome Measures
Change in a depression rating scale at endpoint
Secondary Outcome Measures
Change in a disability scale and Clinical Global Impression scale at endpoint
Full Information
NCT ID
NCT00095758
First Posted
November 9, 2004
Last Updated
November 22, 2013
Sponsor
Bristol-Myers Squibb
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00095758
Brief Title
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
Official Title
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1200 (false)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Placebo Comparator
Arm Title
A2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Antidepressant + Placebo
Intervention Description
Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
Intervention Type
Drug
Intervention Name(s)
Antidepressant + Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
Primary Outcome Measure Information:
Title
Change in a depression rating scale at endpoint
Secondary Outcome Measure Information:
Title
Change in a disability scale and Clinical Global Impression scale at endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Local Institution
City
Burbank
State/Province
California
Country
United States
Facility Name
Local Institution
City
National City
State/Province
California
Country
United States
Facility Name
Local Institution
City
Orange
State/Province
California
Country
United States
Facility Name
Local Institution
City
Pasadena
State/Province
California
Country
United States
Facility Name
Local Institution
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Local Institution
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Local Institution
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Local Institution
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Arlington
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Herndon
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Local Institution
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Local Institution
City
Brown Deer
State/Province
Wisconsin
Country
United States
Facility Name
Local Institution
City
Middleton
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19192475
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.
Results Reference
background
PubMed Identifier
20098527
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.
Results Reference
background
PubMed Identifier
19287552
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.
Results Reference
background
PubMed Identifier
18344725
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.
Results Reference
background
PubMed Identifier
19593176
Citation
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.
Results Reference
background
PubMed Identifier
24766999
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.
Results Reference
derived
PubMed Identifier
23106023
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.
Results Reference
derived
PubMed Identifier
23585999
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.
Results Reference
derived
PubMed Identifier
23585997
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.
Results Reference
derived
PubMed Identifier
21731833
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.
Results Reference
derived
PubMed Identifier
20816039
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.
Results Reference
derived
PubMed Identifier
18832427
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.
Results Reference
derived
Learn more about this trial
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
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