Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:May 2009
End Date:July 2010

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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an
assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an
incomplete response to a prospective eight week trial of the same assigned open-label
marketed ADT.

A comparison of the Fixed dose arm (OPC-31712, 0.15 mg) verses placebo was included as a
general secondary efficacy variable and results for this dose group comparison are included
under each of the Outcome Measures.

Inclusion Criteria:

- Male or female subjects between 18 and 65 years of age, with diagnosis of major
depressive disorder, as defined by DSM-IV-TR 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:

- Females who are breast-feeding and/or who have a positive pregnancy test result prior
to receiving study drug.

- 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.
We found this trial at
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Smyrna, Georgia 30080
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901 Boren Avenue
Seattle, Washington 98104
206-624-4587
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3212 Cove Bend Drive
Tampa, Florida 33613
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Arcadia, California 91007
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Austin, Texas 78754
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Austin, Texas 78756
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Baltimore, Maryland 21208
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Beachwood, Ohio 44122
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Bellevue, Washington 98007
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Beverly Hills, California 90210
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8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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Brown Deer, Wisconsin 53223
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Canton, OH
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Charlotte, North Carolina 28211
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Charlottesville, Virginia 22903
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Chicago, Illinois 60640
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Cinncinnati, Ohio 45242
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Columbia, SC
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Coral Springs, Florida 33067
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Dayton, OH
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Denver, Colorado 80239
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Escondido, California 92025
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Fort Myers, Florida 33912
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Garden Grove, California 92845
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Herndon, Virginia 20170
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32216
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Kissimee, Florida 34741
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Media, Pennsylvania 19063
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Memphis, Tennessee 38119
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Middleburg Heights, Ohio 44130
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Middleton, Wisconsin 53562
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Midlothian, Virginia 23112
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Mount Kisco, New York 10549
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National City, California 91950
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New York, New York 10023
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New York City, New York 10021
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Oakbrook Terrace, Illinois 60181
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Oceanside, California 92056
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Orlando, Florida 32806
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Overland Park, Kansas 23112
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Portland, Oregon 97210
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Rochester, New York 14618
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Salt Lake City, Utah 84107
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Salt Lake City, Utah 84132
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San Diego, California 92108
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Sherman Oaks, CA
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West Palm Beach, Florida 33407
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