Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)

• Status: Completed
• Trial end date: 2018-09-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Fluoxetine; Vilazodone Hydrochloride

Criteria

Inclusion Criteria:

• Male or Female outpatients between 7-17 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