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



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:7 - 17
Updated:10/25/2018
Start Date:February 28, 2015
End Date:September 11, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
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Bayou City Research, Ltd.
Houston, Texas 77024
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Institute for Advanced Medical Research
Alpharetta, Georgia 30005
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Atlantic Center for Medical Research
501 Fairburn Road Southwest
Atlanta, Georgia 30331
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FutureSearch Clinical Trials
Austin, Texas 78756
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BioBehavioral Research of Austin
Austin, Texas 78759
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Haidar Almhana Nieding LLC
223 Miller Road
Avon Lake, Ohio 44012
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Hugo W. Moser Research Institute at Kennedy Krieger Inc.
Baltimore, Maryland 21205
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Pharmsite Research Inc.
1314 Bedford Avenue
Baltimore, Maryland 21208
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Northwest Clinical Research Center
Bellevue, Washington 98007
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CITrials - Bellflower
17800 Woodruff Avenue
Bellflower, California 90706
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Alliance Clinical Research
Birmingham, Alabama 35215
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Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio 44718
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UVA Center for Psychopharmacology Research in Youth
405 Emmet Street South
Charlottesville, Virginia 22903
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University of Cincinnati
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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University Hospitals Cleveland Medical Center, Psychiatry
10524 Euclid Avenue
Cleveland, Ohio 44106
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Ericksen Research And Development
Clinton, Utah 84015
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Ohio State University, Dept. of Psychiatry
Columbus, Ohio 43210
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ATP Clinical Research, Inc.
Costa Mesa, California 92626
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Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri 63141
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University of TX Southwestern Medical Ctr
5323 Harry Hines Boulevard
Dallas, Texas 75235
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Harmonex Neuroscience Research
Dothan, Alabama 36303
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Core Clinical Research
Everett, Washington 98201
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Behavioral Research Specialists, LLC
Glendale, California 91204
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The Hartford Hospital
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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Palm Springs Research, LLC
Hialeah, Florida 33012
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IMIC Inc.
18320 Franjo Road
Homestead, Florida 33030
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Houston Endoscopy and Research Center
Houston, Texas 77079
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Goldpoint Clinical Research
Indianapolis, Indiana 46260
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Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida 32216
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Okanagan Clinical Trials
1353 Ellis Street
Kelowna, British Columbia V1Y 1Z9
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Osceola Mental Health dba Park Place Behavioral Health Care
206 Park Place Boulevard
Kissimmee, Florida 34741
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Lake Charles Clinical Trials LLC
Lake Charles, Louisiana 70601
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Innovative Clinical Research, Inc
Lauderhill, Florida 33319
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Capstone Clinical Research
Libertyville, Illinois 60048
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Woodland International Research Group, Inc.
Little Rock, Arkansas 72211
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Northwest Behavioral Research Center
Marietta, Georgia 30060
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Professional Psychiatric Services
Mason, Ohio 45040
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Research Strategies of Memphis, LLC
Memphis, Tennessee 38119
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Bioscience Research, Llc
Mount Kisco, New York 10549
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Baber Research Group
Naperville, Illinois 60563
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Manhattan Behavioral Medicine, LLC
New York, New York 10022
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Neuroscience Research Institute, Inc
Oak Park, Illinois 60301
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IPS Research Company
Oklahoma City, Oklahoma 73103
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Cutting Edge Research Group
Oklahoma City, Oklahoma 73116
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Clinical Neuroscience Solutions, Inc
Orlando, Florida 32806
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Psychiatric Associates
Overland Park, Kansas 66211
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Phoenix Children's Hospital
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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Research Across America
Plano, Texas 75093
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Finger Lakes Clinical Research
Rochester, New York 14618
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Neuroscientific Insights
Rockville, Maryland 20852
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St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri 63301
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Focus and Balance, LLC
San Antonio, Texas 78229
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PCSD - Feighner Research
San Diego, California 92108
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Baystate Medical Center
759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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Richmond Behavioral Associates
Staten Island, New York 10312
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Family Psychiatry of the Woodlands
The Woodlands, Texas 77381
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Pacific Clinical Research Medical Group
Upland, California 91786
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Childrens National Medical Center
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Adams Clinical Trials LLC
Watertown, Massachusetts
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