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

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT02372799

Run by

Forest Laboratories

People needed

473

Starts

2015-02-28

Expected to finish

2018-09-11

Last updated by the study team

2019-10-01

Who can join

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

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

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

Full record on ClinicalTrials.gov

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