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VLZ-MD-21: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients with Major Depressive Disorder

Principal Investigator:
Robert
Findling

Purpose

This is a double-blind, randomized, placebo-controlled, fixed-dose trial designed to evaluate the efficacy, safety, and tolerability of vilazodone for the treatment of major depressive disorder in adolescents (ages 12-17, inclusive).

A secondary goal is to utilize pharmacokinetic data obtained from this study to guide dose selection for future studies in younger subjects (ages 7-11, inclusive).

Design

This study consists of 3 groups: (1) Placebo drug, (2) 15 mg/day vilazodone, and (3) 30 mg/day vilazodone. Placebo and active drugs will be administered orally (3 tablets, daily). Trial duration is 10 weeks including: a 1-week screening period, an 8-week period of double-blind treatment, and a 1-week double-blind, down-taper period.

Efficacy

Efficacy measurements for the primary goal of the study involve psychiatric evaluations (CDRS-R, CGI-S, and CGI-I). Pharmacokinetic studies from serial blood draws of a subset of participants (optional extension to the main protocol) will be performed to achieve the secondary goal of this study.

Safety

Safety monitoring will include assessment of adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, and the Columbia-Suicide Severity Rating Scale.

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