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

September 11, 2019 updated by: Forest Laboratories

A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

473

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

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Okanagan Clinical Trials
    • Ontario
      • Toronto, Ontario, Canada, M5B 1T8
        • Paediatric Sleep Research Inc
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Alliance Clinical Research
      • Dothan, Alabama, United States, 36303
        • Harmonex Neuroscience Research
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group, Inc
    • California
      • Bellflower, California, United States, 90706
        • CITrials - Bellflower
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists, LLC
      • San Diego, California, United States, 92108
        • PCSD - Feighner Research
      • Upland, California, United States, 91786
        • Pacific Clinical Research Medical Group
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Hialeah, Florida, United States, 33012
        • Palm Springs Research, LLC
      • Homestead, Florida, United States, 33030
        • IMIC Inc.
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Kissimmee, Florida, United States, 34741
        • Osceola Mental Health dba Park Place Behavioral Health Care
      • Lauderhill, Florida, United States, 33319
        • Innovative Clinical Research, Inc.
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Institute for Advanced Medical Research
      • Atlanta, Georgia, United States, 30331
        • Atlantic Center for Medical Research
      • Marietta, Georgia, United States, 30060
        • Northwest Behavioral Research Center
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Capstone Clinical Research
      • Naperville, Illinois, United States, 60563
        • Baber Research Group
      • Oak Park, Illinois, United States, 60301
        • Neuroscience Research Institute Inc.
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Goldpoint Clinical Research, LLC
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Psychiatric Associates
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • Lake Charles Clinical Trials
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Hugo W Moser Research Institute at Kennedy Krieger, Inc.
      • Baltimore, Maryland, United States, 21208
        • Pharmsite Research Inc.
      • Rockville, Maryland, United States, 20852
        • Neuroscientific Insights
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Watertown, Massachusetts, United States, 02472
        • Adams Clinical Trials, LLC
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Millennium Psychiatric Associates
      • Saint Charles, Missouri, United States, 63304
        • St. Charles Psychiatric Associates - Midwest Research Group
    • New York
      • Mount Kisco, New York, United States, 10549
        • Bioscience Research LLC
      • New York, New York, United States, 10022
        • Manhattan Behavioral Medicine
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Haidar Almhana Nieding LLC
      • Canton, Ohio, United States, 44718
        • Neuro-Behavioral Clinical Research, Inc
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Psychiatry
      • Columbus, Ohio, United States, 43210
        • Ohio State Univ. Dept of Psychiatry
      • Mason, Ohio, United States, 45040
        • Professional Psychiatric Services
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research Group
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Strategies of Memphis LLC
    • Texas
      • Austin, Texas, United States, 78759
        • BioBehavioral Research of Austin, PC
      • Austin, Texas, United States, 78731
        • FutureSearch Clinical trials, Inc.
      • Dallas, Texas, United States, 75235
        • University of TX Southwestern Medical Ctr
      • Houston, Texas, United States, 77079
        • Houston Endoscopy and Research Ctr
      • Houston, Texas, United States, 77007
        • Bayou City Research Ltd
      • Plano, Texas, United States, 75234
        • Research Across America
      • San Antonio, Texas, United States, 78229
        • Focus and Balance
      • The Woodlands, Texas, United States, 77381
        • Family Psychiatry of The Woodlands
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research and Development
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Center for Psychopharmacology Research in Youth
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Everett, Washington, United States, 98033
        • Core Clinical Research

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

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female outpatients between 7-17 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
Experimental: Vilazodone
Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
Drug: Vilazodone
Other Names:
  • Viibryd
Placebo Comparator: Placebo
Dose-matched placebo tablets or capsules, oral administration, once per day.
Drug: Placebo
Active Comparator: Fluoxetine
Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.
Drug: Fluoxetine
Other Names:
  • Prozac

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

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)

February 28, 2015

Primary Completion (Actual)

September 11, 2018

Study Completion (Actual)

September 11, 2018

Study Registration Dates

First Submitted

February 21, 2015

First Submitted That Met QC Criteria

February 21, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VLZ-MD-22

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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