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

Study ID
VLZ-MD-21

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact


Principal Investigator

Official Title

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

Brief Overview


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.

Participant Eligibility


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