Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
NCT ID: NCT01447576
Last Updated: 2015-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1036 participants
INTERVENTIONAL
2009-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OPC-34712 + ADT
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment
ADT
Once daily dosing during the duration of the study.
OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Interventions
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ADT
Once daily dosing during the duration of the study.
OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the Baseline visit).
* Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four 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, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress 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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Pacific Clinical Research Medical Group
Arcadia, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, United States
Florida Clinical Research Center
Maitland, Florida, United States
Clinical Neurosciences Solutions
Orlando, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Carman Research
Smyrna, Georgia, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Pharmasite Research
Baltimore, Maryland, United States
Clinical Insights
Glen Burnie, Maryland, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Brooklyn Medical Institute
Brooklyn, New York, United States
Medical & Behavioral Health Research
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States
Oregon Center for Clinical Investigations
Salem, Oregon, United States
Carolina Clinical Research Services
Columbia, South Carolina, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Radiant Research
Murray, 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, Washington, United States
Northbrooke Research Center
Brown Deer, Wisconsin, United States
Dean Foundation
Middleton, Wisconsin, United States
Countries
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Other Identifiers
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331-08-212
Identifier Type: -
Identifier Source: org_study_id
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