Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder

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 relative to placebo in adolescent outpatients (12-17) with major depressive disorder.

Key facts

Study ID

NCT01878292

Run by

Forest Laboratories

People needed

529

Starts

2013-07-11

Expected to finish

2016-10-05

Last updated by the study team

2019-12-24

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female outpatients between 12-17 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

• Forest Investigative Site 052 — Los Angeles, California, United States
• Forest Investigative Site 023 — Murrieta, California, United States
• Forest Investigative Site 004 — Orange, California, United States
• Forest Investigative Site 037 — San Diego, California, United States
• Forest Investigative Site 006 — Washington D.C., District of Columbia, United States
• Forest Investigative Site 039 — Gainesville, Florida, United States
• Forest Investigative Site 009 — Jacksonville Beach, Florida, United States
• Forest Investigative Site 063 — Miami, Florida, United States
• Forest Investigative Site 034 — Oakland Park, Florida, United States
• Forest Investigative Site 016 — Orlando, Florida, United States
• Forest Investigative Site 064 — Orlando, Florida, United States
• Forest Investigative Site 014 — Atlanta, Georgia, United States
• Forest Investigative Site 030 — Roswell, Georgia, United States
• Forest Investigative Site 032 — Libertyville, Illinois, United States
• Forest Investigative Site 048 — Naperville, Illinois, United States
• Forest Investigative Site 051 — Terre Haute, Indiana, United States
• Forest Investigative Site 013 — Overland Park, Kansas, United States
• Forest Investigative Site 070 — Lake Charles, Louisiana, United States
• Forest Investigative Site 050 — Baltimore, Maryland, United States
• Forest Investigative Site 054 — Baltimore, Maryland, United States
• Forest Investigative Site 049 — Rockville, Maryland, United States
• Forest Investigative Site 026 — Watertown, Massachusetts, United States
• Forest Investigative Site 024 — Rochester Hills, Michigan, United States
• Forest Investigative Site 015 — Creve Coeur, Missouri, United States
• Forest Investigative Site 073 — Imperial, California, United States

Full record on ClinicalTrials.gov

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