Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder



Status:Active, not recruiting
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 17
Updated:6/17/2016
Start Date:July 2013
End Date:August 2016

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A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of
vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive
disorder.


Inclusion Criteria:

- Male or Female outpatients between 12-17 years of age

- Primary diagnosis of major depressive disorder (MDD)

- Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater

- Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

- Current (past 3 months) principal Diagnostic and Statistical Manual of Mental
Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder
other than major depressive disorder (MDD) that is the primary focus of treatment.

- History of suicidal behavior, or requires precaution against suicide

- Not generally healthy medical condition

- Seizure disorder
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52
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Neptune, New Jersey 07753
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Albuquerque, New Mexico 87109
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Atlanta, Georgia 30328
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Baltimore, Maryland 21285
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Canton, Ohio 44718
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Charleston, South Carolina 29407
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Cherry Hill, New Jersey 08002
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Cincinnati, Ohio 45219
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Clinton, Utah 84015
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Columbus, Ohio 43213
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Creve Coeur, Missouri 63141
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Dallas, Texas 75230
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Durham, North Carolina 27710
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Gainesville, Florida 32607
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Houston, Texas 77008
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Imperial, California 92251
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Jacksonville Beach, Florida 32250
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Kirkland, Washington 98033
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Naperville, Illinois 60563
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Oakland Park, Florida 33334
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Philadelphia, Pennsylvania 19139
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Terre Haute, Indiana 47802
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Washington, District of Columbia 20010
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