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

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.

Timeline

Start

2013-07-11

Primary completion

2016-03-17

Completion

2016-10-05

Outcome

Missed primary endpoint

paper There was no statistically significant difference between vilazodone 15 mg/day or 30 mg/day and placebo in change from baseline in CDRS-R score. PMID 29633166 ↗

Publications

• Durgam S, Chen C, Migliore R, Prakash C, Edwards J, Findling RL. A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder. Paediatr Drugs. 2018 Aug;20(4):353-363. doi: 10.1007/s40272-018-0290-4.

Drugs

Indications