Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder (VLZ-MD-21)

December 6, 2019 updated by: Forest Laboratories

A Double-Blind, Placebo-Controlled Evaluation of the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

529

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Imperial, California, United States, 92251
        • Forest Investigative Site 073
      • Los Angeles, California, United States, 90027
        • Forest Investigative Site 052
      • Murrieta, California, United States, 92562
        • Forest Investigative Site 023
      • Orange, California, United States, 92868
        • Forest Investigative Site 004
      • San Diego, California, United States, 92108
        • Forest Investigative Site 037
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Forest Investigative Site 006
    • Florida
      • Gainesville, Florida, United States, 32607
        • Forest Investigative Site 039
      • Jacksonville Beach, Florida, United States, 32250
        • Forest Investigative Site 009
      • Miami, Florida, United States, 33155
        • Forest Investigative Site 063
      • Oakland Park, Florida, United States, 33334
        • Forest Investigative Site 034
      • Orlando, Florida, United States, 32803
        • Forest Investigative Site 016
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 064
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Forest Investigative Site 014
      • Roswell, Georgia, United States, 30076
        • Forest Investigative Site 030
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Forest Investigative Site 032
      • Naperville, Illinois, United States, 60563
        • Forest Investigative Site 048
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • Forest Investigative Site 051
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Forest Investigative Site 013
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • Forest Investigative Site 070
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Forest Investigative Site 050
      • Baltimore, Maryland, United States, 21208
        • Forest Investigative Site 054
      • Rockville, Maryland, United States, 20852
        • Forest Investigative Site 049
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Forest Investigative Site 026
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Forest Investigative Site 024
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Forest Investigative Site 015
      • Saint Charles, Missouri, United States, 63304
        • Forest Investigative Site 055
      • Saint Louis, Missouri, United States, 63128
        • Forest Investigative Site 072
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Forest Investigative Site 066
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Forest Investigative Site 007
      • Neptune, New Jersey, United States, 07752
        • Forest Investigative Site 071
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Forest Investigative Site 008
    • New York
      • Rochester, New York, United States, 14618
        • Forest Investigative Site 057
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Forest Investigative Site 059
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Forest Investigative Site 053
      • Canton, Ohio, United States, 44718
        • Forest Investigative Site 021
      • Cincinnati, Ohio, United States, 45219
        • Forest Investigative Site 012
      • Columbus, Ohio, United States, 43210
        • Forest Investigative Site 029
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site 011
      • Oklahoma City, Oklahoma, United States, 73103
        • Forest Investigative Site 018
      • Tulsa, Oklahoma, United States, 74104
        • Forest Investigative Site 065
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Forest Investigative Site 040
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Forest Investigative Site 074
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 062
    • Texas
      • Dallas, Texas, United States, 75235
        • Forest Investigative Site 001
      • Houston, Texas, United States, 77098
        • Forest Investigative Site 027
      • Plano, Texas, United States, 75093
        • Forest Investigative Site 041
      • The Woodlands, Texas, United States, 77381
        • Forest Investigative Site 045
    • Utah
      • Clinton, Utah, United States, 84015
        • Forest Investigative Site 019
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Forest Investigative Site 060
    • Washington
      • Bellevue, Washington, United States, 98007
        • Forest Investigative Site 035
      • Bothell, Washington, United States, 98011
        • Forest Investigative Site 068
      • Kirkland, Washington, United States, 98033
        • Forest Investigative Site 022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dose-matched placebo tablets, once per day, oral administration
Drug: Placebo
Dose matched placebo tablets, once per day, oral administration.
Experimental: Vilazodone 15 mg
15 mg vilazodone tablets, once per day, oral administration
Drug: Vilazodone
Vilazodone tablets, 15 mg per day, oral administration
Other Names:
  • Viibryd
Drug: Vilazodone
Vilazodone tablets, 30 mg once per day, oral administration
Other Names:
  • Viibryd
Experimental: vilazodone 30 mg
30 mg vilazodone tablets, once per day, oral administration
Drug: Vilazodone
Vilazodone tablets, 15 mg per day, oral administration
Other Names:
  • Viibryd
Drug: Vilazodone
Vilazodone tablets, 30 mg once per day, oral administration
Other Names:
  • Viibryd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Baseline to week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Chandran Prakash, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2013

Primary Completion (Actual)

March 17, 2016

Study Completion (Actual)

October 5, 2016

Study Registration Dates

First Submitted

June 11, 2013

First Submitted That Met QC Criteria

June 12, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VLZ-MD-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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