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Completed

NCT Number: NCT01878292

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site 073, Imperial, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female outpatients between 12-17 years of age
  • Primary diagnosis of major depressive disorder (MDD)
  • Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
  • Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion criteria

  • Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
  • History of suicidal behavior, or requires precaution against suicide
  • Not generally healthy medical condition
  • Seizure disorder

Treatment and study plan

Placebo

Drug

Dose matched placebo tablets, once per day, oral administration.

Vilazodone

Drug

Vilazodone tablets, 15 mg per day, oral administration

Other names: Viibryd

Primary outcomes

  1. Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score

    Time frame: From Baseline to week 8

    The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.

Secondary outcomes

  1. Change in Clinical Global Impressions-Severity (CGI-S) Score

    Time frame: From Baseline to Week 8

    The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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

Acronym: VLZ-MD-21

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 14, 2013
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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