Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
NCT ID: NCT01052077
Last Updated: 2015-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
773 participants
INTERVENTIONAL
2010-03-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Brexipiprazole + ADT
OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
OPC-34712
Tablets, Oral, 1 - 3 mg OPC-34712
Placebo
Placebo
ADT
Placebo + ADT
Placebo + ADT
Placebo
Placebo
ADT
Interventions
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OPC-34712
Tablets, Oral, 1 - 3 mg OPC-34712
Placebo
Placebo
ADT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The current depressive episode must be equal to or greater than 8 weeks in duration
* Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments.
Exclusion Criteria
* Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
* Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder
* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Pacific Clinical Research Medical Group
Arcadia, California, United States
Southwestern Research
Beverly Hills, California, United States
Excell Research
Oceanside, California, United States
Affiliated Research Institute
San Diego, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
CNS Clinical Research Group
Coral Springs, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Clinical InSights
Glen Burnie, Maryland, United States
Pharmasite Research, Inc.
Pikesville, Maryland, United States
MSU/Institute for Health Studies
East Lansing, Michigan, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Eastside Comprehensive Medical Center
New York, New York, United States
Medical & Behavioral Health Research, PC
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Northcoast Clinical Trials
Beachwood, Ohio, United States
Patient Priority Clinical sites, LLC
Cincinnati, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon), LLC
Portland, Oregon, United States
City Line Avenue Family Practice
Bala-Cynwyd, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lincoln Research
Lincoln, Rhode Island, United States
Clinical NeuroScience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Radiant Research
Salt Lake City, Utah, United States
Psychiatric Alliance of The Blue Ridge
Charlottesville, Virginia, United States
NeuroScience, Inc.
Herndon, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, United States
Northbrooke Research Center
Brown Deer, Wisconsin, United States
Countries
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References
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Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.
Other Identifiers
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331-09-222
Identifier Type: -
Identifier Source: org_study_id
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