NCT02372799

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

A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Vilazodone
DRUG	Placebo
DRUG	Fluoxetine

Timeline

• Start date: 2015-02-28
• Primary completion: 2018-09-11
• Completion: 2018-09-11
• First posted: 2015-02-26
• Last updated: 2019-10-01
• Results posted: 2019-10-01

Locations

60 sites across 2 countries: United States, Canada