Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
VLZ-MD-22
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
1 other identifier
interventional
473
2 countries
60
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 major-depressive-disorder
Started Feb 2015
Longer than P75 for phase_3 major-depressive-disorder
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedStudy Start
First participant enrolled
February 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2018
CompletedResults Posted
Study results publicly available
October 1, 2019
CompletedOctober 1, 2019
September 1, 2019
3.5 years
February 21, 2015
September 11, 2019
September 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
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 Outcomes (1)
Change in Clinical Global Impressions-Severity (CGI-S) Score
From Baseline to Week 8
Study Arms (3)
Vilazodone
EXPERIMENTALVilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
Placebo
PLACEBO COMPARATORDose-matched placebo tablets or capsules, oral administration, once per day.
Fluoxetine
ACTIVE COMPARATORFluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Alliance Clinical Research
Birmingham, Alabama, 35213, United States
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Woodland International Research Group, INC
Little Rock, Arkansas, 72211, United States
CITrials - Bellflower
Bellflower, California, 90706, United States
ATP Clinical Research
Costa Mesa, California, 92626, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
PCSD - Feighner Research
San Diego, California, 92108, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Palm Springs Research, LLC
Hialeah, Florida, 33012, United States
IMIC Inc.
Homestead, Florida, 33030, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Osceola Mental Health dba Park Place Behavioral Health Care
Kissimmee, Florida, 34741, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, 30005, United States
Atlantic Center for Medical Research
Atlanta, Georgia, 30331, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Baber Research Group
Naperville, Illinois, 60563, United States
Neuroscience Research Institute Inc.
Oak Park, Illinois, 60301, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629, United States
Hugo W Moser Research Institute at Kennedy Krieger, Inc.
Baltimore, Maryland, 21205, United States
Pharmsite Research Inc.
Baltimore, Maryland, 21208, United States
NeuroScientific Insights
Rockville, Maryland, 20852, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472, United States
Millennium Psychiatric Associates
Creve Coeur, Missouri, 63141, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304, United States
BioScience Research LLC
Mount Kisco, New York, 10549, United States
Manhattan Behavioral Medicine
New York, New York, 10022, United States
Finger Lakes Clinical research
Rochester, New York, 14618, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Haidar Almhana Nieding LLC
Avon Lake, Ohio, 44012, United States
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, 44718, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center, Psychiatry
Cleveland, Ohio, 44106, United States
Ohio State Univ. Dept of Psychiatry
Columbus, Ohio, 43210, United States
Professional Psychiatric Services
Mason, Ohio, 45040, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Research Strategies of Memphis LLC
Memphis, Tennessee, 38119, United States
FutureSearch Clinical trials, Inc.
Austin, Texas, 78731, United States
BioBehavioral Research of Austin, PC
Austin, Texas, 78759, United States
University of TX Southwestern Medical Ctr
Dallas, Texas, 75235, United States
Bayou City Research Ltd
Houston, Texas, 77007, United States
Houston Endoscopy and Research Ctr
Houston, Texas, 77079, United States
Research Across America
Plano, Texas, 75234, United States
Focus and Balance
San Antonio, Texas, 78229, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381, United States
Ericksen Research and Development
Clinton, Utah, 84015, United States
UVA Center for Psychopharmacology Research in Youth
Charlottesville, Virginia, 22903, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Core Clinical Research
Everett, Washington, 98033, United States
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
Paediatric Sleep Research Inc
Toronto, Ontario, M5B 1T8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Emily McCusker, PhD
Forest Research Institute, an affiliate of Allergan plc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2015
First Posted
February 26, 2015
Study Start
February 28, 2015
Primary Completion
September 11, 2018
Study Completion
September 11, 2018
Last Updated
October 1, 2019
Results First Posted
October 1, 2019
Record last verified: 2019-09