Status:
COMPLETED
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Lead Sponsor:
Forest Laboratories
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2016
Estimated Enrollment :
529 Patients enrolled
Trial Details
Trial ID
NCT01878292
Start Date
July 11 2013
End Date
October 5 2016
Last Update
December 24 2019
Active Locations (52)
Enter a location and click search to find clinical trials sorted by distance.
1
Forest Investigative Site 073
Imperial, California, United States, 92251
2
Forest Investigative Site 052
Los Angeles, California, United States, 90027
3
Forest Investigative Site 023
Murrieta, California, United States, 92562
4
Forest Investigative Site 004
Orange, California, United States, 92868