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

NCT02372799 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2019-10-01

Study results available
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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

Interventions

DRUG

Vilazodone

DRUG

Placebo

DRUG

Fluoxetine

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Emily McCusker, PhD · Forest Research Institute, an affiliate of Allergan plc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-09-11
Completion
2018-09-11

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02372799 on ClinicalTrials.gov