A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

Last updated: September 10, 2019
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

3

Condition

Affective Disorders

Depression (Major/severe)

Depression

Treatment

N/A

Clinical Study ID

NCT02436239
VLZ-MD-23
  • Ages 7-17
  • All Genders

Study Summary

The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or Female outpatients betw een 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

Exclusion Criteria:

  • Current (past 3 months) principal Diagnostic and Statistical Manual of MentalDisorders, Fourth Edition, Text Revision based diagnosis of an Axis I disorder otherthan MDD that is the primary focus of treatment (de novo patients only)

  • History of suicidal behavior, or requires precaution against suicide

  • Not generally healthy medical condition

  • Seizure disorder

Study Design

Total Participants: 330
Study Start date:
May 02, 2015
Estimated Completion Date:
July 23, 2018

Connect with a study center

  • Okanagan Clinical Trials Inc.

    Kelowna, British Columbia V1Y1Z9
    Canada

    Site Not Available

  • Paediatric Sleep Research Inc

    Toronto, Ontario M6J3S3
    Canada

    Site Not Available

  • Alliance Clinical Research

    Birmingham, Alabama 35213
    United States

    Site Not Available

  • Harmonex Neuroscience Research

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Woodland International Research Group, INC

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • CITrials - Bellflower

    Bellflower, California 90706
    United States

    Site Not Available

  • ATP Clinical Research

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Behavioral Research Specialists, LLC

    Glendale, California 91206
    United States

    Site Not Available

  • Investigative Site 032

    Orange, California 92868
    United States

    Site Not Available

  • PCSD - Feighner Research

    San Diego, California 92108
    United States

    Site Not Available

  • Pacific Clinical Research Medical Group

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Palm Springs Research, LLC

    Hialeah, Florida 33012
    United States

    Site Not Available

  • IMIC Inc.

    Homestead, Florida 33030
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Investigative Site 039

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Innovative Clinical Research, Inc.

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

    Site Not Available

  • Investigative Site 051

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Institute for Advanced Medical Research

    Alpharetta, Georgia 30005
    United States

    Site Not Available

  • Atlantic Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Northwest Behavioral Research Center

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Capstone Clinical Research

    Libertyville, Illinois 60048
    United States

    Site Not Available

  • Baber Research Group

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Neuroscience Research Institute Inc.

    Oak Park, Illinois 60301
    United States

    Site Not Available

  • Investigative Site 057

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Investigative Site 024

    Terre Haute, Indiana 47802
    United States

    Site Not Available

  • Psychiatric Associates

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana 70629
    United States

    Site Not Available

  • Hugo W Moser Research Institute at Kennedy Krieger, Inc.

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Pharmsite Research Inc.

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • NeuroScientific Insights

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • Adams Clinical Trials, LLC

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Millennium Psychiatric Associates

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Investigative Site 040

    St. Charles, Missouri 63304
    United States

    Site Not Available

  • Erie County Medical Center/State University of New York of Buffalo Affiliate

    Buffalo, New York 14215
    United States

    Site Not Available

  • BioScience Research LLC

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Investigative Site 029

    Mt Kisco, New York 10549
    United States

    Site Not Available

  • Manhattan Behavioral Medicine

    New York, New York 10022
    United States

    Site Not Available

  • Finger Lakes Clinical research

    Rochester, New York 14618
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10312
    United States

    Site Not Available

  • Haidar Almhana Nieding LLC

    Avon Lake, Ohio 44012
    United States

    Site Not Available

  • Neuro-Behavioral Clinical Research, Inc

    Canton, Ohio 44718
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center, Psychiatr

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio State Univ. Dept of Psychiatry

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Professional Psychiatric Services

    Mason, Ohio 45040
    United States

    Site Not Available

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • IPS Research Company

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Research Strategies of Memphis LLC

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • BioBehavioral Research of Austin, PC

    Austin, Texas 78759
    United States

    Site Not Available

  • Investigative Site 034

    Dallas, Texas 75235
    United States

    Site Not Available

  • Houston Endoscopy and Research Ctr

    Houston, Texas 77079
    United States

    Site Not Available

  • UT Health Science Center at Houston

    Houston, Texas 77054
    United States

    Site Not Available

  • Research Across America

    Plano, Texas 75093
    United States

    Site Not Available

  • Focus and Balance

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Family Psychiatry of The Woodlands

    The Woodlands, Texas 77381
    United States

    Site Not Available

  • Ericksen Research and Development

    Clinton, Utah 84015
    United States

    Site Not Available

  • UVA Center for Psychopharmacology Research in Youth

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Core Clinical Research

    Kirkland, Washington 98033
    United States

    Site Not Available

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