Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD), Psychiatric, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:8/23/2018
Start Date:July 2014
End Date:May 2016

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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

The purpose of this study is to assess the tolerability, safety, and efficacy of
brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD
with and without anxious distress

The introduction of atypical antipsychotics has created a renewed interest in adjunctive
therapy for MDD, particularly for treatment-resistant MDD. Several atypical antipsychotics
have been shown to enhance the response to ADT. This is a phase 3, multicenter, randomized,
double-blind, placebo-controlled, fixed-dose trial designed to assess the safety and efficacy
of brexpiprazole (2.0 mg/day) as adjunctive therapy to an assigned open-label ADT in
depressed subjects with and without anxious distress.

Inclusion Criteria:

- Male and Female subjects between 18-65 years of age, with diagnosis of major
depressive disorder with or without anxious distress

- Current depressive episode must be at least 8 weeks in duration

Exclusion Criteria:

- Subjects with a history of Neuroleptic Malignant Syndrome or Serotonin Syndrome

- Subjects who report an inadequate response to more than 3 antidepressant treatments in
the current episode

- Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other
cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic
disorder, Bipolar I or II disorder
We found this trial at
31
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Memphis, TN
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Achim,
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Baltimore, MD
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Beverly Hills, California 90211
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Cherry Hill, NJ
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1880
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Cincinnati, OH
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Columbia, SC
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Denver, CO
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Edmond, OK
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Hialeah, FL
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Jamaica, NY
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Lincoln, RI
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565
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Murray, UT
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New York, NY
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Orlando, FL
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2375
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Philadelphia, PA
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Portland, OR
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Raleigh, NC
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Richmond, VA
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Rochester Hills, Michigan 48085
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Rochester Hills, MI
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Salem, OR
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Smyrna, GA
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Staten Island, NY
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Wichita Falls, TX
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Woodstock, VT
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