A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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).

Key facts

Study ID

NCT02436239

Run by

Forest Laboratories

People needed

330

Starts

2015-05-02

Expected to finish

2018-07-23

Last updated by the study team

2019-09-11

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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 — 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
• 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
• 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
• Alliance Clinical Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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