NCT01878292

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 529 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Dose matched placebo tablets, once per day, oral administration.
DRUG	Vilazodone	Vilazodone tablets, 15 mg per day, oral administration
DRUG	Vilazodone	Vilazodone tablets, 30 mg once per day, oral administration

Timeline

• Start date: 2013-07-11
• Primary completion: 2016-03-17
• Completion: 2016-10-05
• First posted: 2013-06-14
• Last updated: 2019-12-24
• Results posted: 2019-12-24

Locations

52 sites across 1 country: United States