A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
VLZ-MD-23
An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
1 other identifier
interventional
330
2 countries
56
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started May 2015
Longer than P75 for phase_3 major-depressive-disorder
56 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
April 28, 2015
CompletedStudy Start
First participant enrolled
May 2, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2018
CompletedResults Posted
Study results publicly available
September 11, 2019
CompletedSeptember 11, 2019
September 1, 2019
3.2 years
April 28, 2015
July 23, 2019
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period
Visit 1 (Week -1) to up to Visit 16 (Week 26)
Secondary Outcomes (3)
Change From Baseline in the CDRS-R Total Score
Baseline (Week 0) to Week 26
Change From Baseline in the CGI-S Score
Baseline (Week 0) to Week 26
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
Baseline (Week 0) to Week 26
Study Arms (1)
Vilazodone
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
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
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
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
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
Erie County Medical Center/State University of New York of Buffalo Affiliate
Buffalo, New York, 14215, 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, Psychiatr
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
BioBehavioral Research of Austin, PC
Austin, Texas, 78759, United States
UT Health Science Center at Houston
Houston, Texas, 77054, United States
Houston Endoscopy and Research Ctr
Houston, Texas, 77079, United States
Research Across America
Plano, Texas, 75093, 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
Kirkland, Washington, 98033, United States
Okanagan Clinical Trials Inc.
Kelowna, British Columbia, V1Y1Z9, Canada
Paediatric Sleep Research Inc
Toronto, Ontario, M6J3S3, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Armin Szegedi, MD, PhD, Vice President CNS Clinical Development
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Emily McCusker, PhD
Forest Research Institute, Inc., 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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 6, 2015
Study Start
May 2, 2015
Primary Completion
July 23, 2018
Study Completion
July 23, 2018
Last Updated
September 11, 2019
Results First Posted
September 11, 2019
Record last verified: 2019-09