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

NCT01878292 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 529

Last updated 2019-12-24

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Chandran Prakash · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-07-11
Primary Completion
2016-03-17
Completion
2016-10-05

Countries

  • United States

Study Locations

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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 NCT01878292 on ClinicalTrials.gov