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



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:March 2010
End Date:November 2011

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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.

This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will
receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive
substance) in addition to an FDA approved antidepressant in order to determine if the study
medication is effective as an add on treatment of MDD.


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
43
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Smyrna, Georgia 30080
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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901 Boren Avenue
Seattle, Washington 98104
206-624-4587
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Arcadia, California 91007
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Atlanta, Georgia 30328
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Austin, Texas 78731
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Bala Cynwyd, Pennsylvania 19004
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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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Brown Deer, Wisconsin 53223
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Cedarhurst, New York 11516
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Charlottesville, Virginia 22903
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Cincinnati, Ohio 45242
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Coral Springs, Florida 33067
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Dallas, Texas 75231
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1066 Bogue Street
East Lansing, Michigan 48824
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Fort Myers, Florida 33912
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Glen Burnie, Maryland 21061
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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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Lincoln, Rhode Island 02865
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Memphis, Tennessee 38119
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New York, New York 10023
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New York, New York 10021
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North Miami, Florida 33161
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Oceanside, California 92056
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Oklahoma City, Oklahoma 73103
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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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Pikesville, Maryland 21208
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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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San Diego, California 92108
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Staten Island, New York 10312
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