A Study of Aripiprazole in Patients With Major Depressive Disorder
NCT ID: NCT00105196
Last Updated: 2013-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
349 participants
INTERVENTIONAL
2005-03-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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A1
Aripiprazole+ ADT
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
A2
Placebo+ ADT
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
Interventions
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Aripiprazole+ ADT
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
Placebo+ ADT
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka America Pharmaceutical
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Cns Clinical Research Group
Coral Springs, Florida, United States
Medical College Of Georgia
Augusta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Uptown Research Institute, Llc
Chicago, Illinois, United States
Cunningham Clinical Research, Llc
Edwardsville, Illinois, United States
Comprehensive Neuroscience, Inc.
Hoffman Estates, Illinois, United States
Vine Street Clinical Research Center
Springfield, Illinois, United States
Clinical Research Institute
Witchita, Kansas, United States
Lsu Health Sciences Center
New Orleans, Louisiana, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Summit Research Network
Farmington Hills, Michigan, United States
Summit Research Network
Flint, Michigan, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Radiant Research Las Vegas
Las Vegas, Nevada, United States
Behavioral Health Center
Charlotte, North Carolina, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Phebe Tucker, Md
Oklahoma City, Oklahoma, United States
Summit Research Network
Portland, Oregon, United States
Suburban Research Associates
Media, Pennsylvania, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Southeast Health Consultants
Charleston, South Carolina, United States
Usc School Of Medicine
Columbia, South Carolina, United States
Community Clinical Research, Inc.
Austin, Texas, United States
Radiant Research, Slc
Salt Lake City, Utah, United States
University Of Utah School Of Medicine
Salt Lake City, Utah, United States
University Of Virginia
Charlottesville, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Northbrooke Research Center
Brown Deer, Wisconsin, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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CN138-165
Identifier Type: -
Identifier Source: org_study_id