Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
NCT ID: NCT02372799
Last Updated: 2019-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
473 participants
INTERVENTIONAL
2015-02-28
2018-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vilazodone
Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
Vilazodone
Placebo
Dose-matched placebo tablets or capsules, oral administration, once per day.
Placebo
Fluoxetine
Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.
Fluoxetine
Interventions
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Vilazodone
Placebo
Fluoxetine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of suicidal behavior, or requires precaution against suicide
* Not generally healthy medical condition
* Seizure disorder
7 Years
17 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Emily McCusker, PhD
Role: STUDY_DIRECTOR
Forest Research Institute, an affiliate of Allergan plc.
Locations
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Alliance Clinical Research
Birmingham, Alabama, United States
Harmonex Neuroscience Research
Dothan, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Woodland International Research Group, INC
Little Rock, Arkansas, United States
CITrials - Bellflower
Bellflower, California, United States
ATP Clinical Research
Costa Mesa, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
PCSD - Feighner Research
San Diego, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Palm Springs Research, LLC
Hialeah, Florida, United States
IMIC Inc.
Homestead, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Osceola Mental Health dba Park Place Behavioral Health Care
Kissimmee, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, United States
Atlantic Center for Medical Research
Atlanta, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Baber Research Group
Naperville, Illinois, United States
Neuroscience Research Institute Inc.
Oak Park, Illinois, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Psychiatric Associates
Overland Park, Kansas, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Hugo W Moser Research Institute at Kennedy Krieger, Inc.
Baltimore, Maryland, United States
Pharmsite Research Inc.
Baltimore, Maryland, United States
NeuroScientific Insights
Rockville, Maryland, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, United States
Millennium Psychiatric Associates
Creve Coeur, Missouri, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
BioScience Research LLC
Mount Kisco, New York, United States
Manhattan Behavioral Medicine
New York, New York, United States
Finger Lakes Clinical research
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Haidar Almhana Nieding LLC
Avon Lake, Ohio, United States
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Psychiatry
Cleveland, Ohio, United States
Ohio State Univ. Dept of Psychiatry
Columbus, Ohio, United States
Professional Psychiatric Services
Mason, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Research Strategies of Memphis LLC
Memphis, Tennessee, United States
FutureSearch Clinical trials, Inc.
Austin, Texas, United States
BioBehavioral Research of Austin, PC
Austin, Texas, United States
University of TX Southwestern Medical Ctr
Dallas, Texas, United States
Bayou City Research Ltd
Houston, Texas, United States
Houston Endoscopy and Research Ctr
Houston, Texas, United States
Research Across America
Plano, Texas, United States
Focus and Balance
San Antonio, Texas, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, United States
Ericksen Research and Development
Clinton, Utah, United States
UVA Center for Psychopharmacology Research in Youth
Charlottesville, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Core Clinical Research
Everett, Washington, United States
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Paediatric Sleep Research Inc
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VLZ-MD-22
Identifier Type: -
Identifier Source: org_study_id
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