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

Major Depressive Disorder Clinical Trial

— VLZ-MD-21  

Official title:

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878292
• Other study ID #: VLZ-MD-21
• Status: Completed
• Phase: Phase 3
• Start date: July 11, 2013
• Est. completion date: October 5, 2016

Study information

• Verified date: December 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: October 5, 2016
• Est. primary completion date: March 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Placebo
Dose matched placebo tablets, once per day, oral administration.
• Vilazodone
Vilazodone tablets, 15 mg per day, oral administration
• Vilazodone
Vilazodone tablets, 30 mg once per day, oral administration

Locations

Country	Name	City	State
United States	Forest Investigative Site 008	Albuquerque	New Mexico
United States	Forest Investigative Site 014	Atlanta	Georgia
United States	Forest Investigative Site 053	Avon Lake	Ohio
United States	Forest Investigative Site 050	Baltimore	Maryland
United States	Forest Investigative Site 054	Baltimore	Maryland
United States	Forest Investigative Site 035	Bellevue	Washington
United States	Forest Investigative Site 068	Bothell	Washington
United States	Forest Investigative Site 021	Canton	Ohio
United States	Forest Investigative Site 074	Charleston	South Carolina
United States	Forest Investigative Site 007	Cherry Hill	New Jersey
United States	Forest Investigative Site 012	Cincinnati	Ohio
United States	Forest Investigative Site 019	Clinton	Utah
United States	Forest Investigative Site 029	Columbus	Ohio
United States	Forest Investigative Site 015	Creve Coeur	Missouri
United States	Forest Investigative Site 001	Dallas	Texas
United States	Forest Investigative Site 059	Durham	North Carolina
United States	Forest Investigative Site 039	Gainesville	Florida
United States	Forest Investigative Site 027	Houston	Texas
United States	Forest Investigative Site 073	Imperial	California
United States	Forest Investigative Site 009	Jacksonville Beach	Florida
United States	Forest Investigative Site 022	Kirkland	Washington
United States	Forest Investigative Site 070	Lake Charles	Louisiana
United States	Forest Investigative Site 066	Las Vegas	Nevada
United States	Forest Investigative Site 032	Libertyville	Illinois
United States	Forest Investigative Site 052	Los Angeles	California
United States	Forest Investigative Site 062	Memphis	Tennessee
United States	Forest Investigative Site 063	Miami	Florida
United States	Forest Investigative Site 023	Murrieta	California
United States	Forest Investigative Site 048	Naperville	Illinois
United States	Forest Investigative Site 071	Neptune	New Jersey
United States	Forest Investigative Site 034	Oakland Park	Florida
United States	Forest Investigative Site 011	Oklahoma City	Oklahoma
United States	Forest Investigative Site 018	Oklahoma City	Oklahoma
United States	Forest Investigative Site 004	Orange	California
United States	Forest Investigative Site 016	Orlando	Florida
United States	Forest Investigative Site 064	Orlando	Florida
United States	Forest Investigative Site 013	Overland Park	Kansas
United States	Forest Investigative Site 040	Philadelphia	Pennsylvania
United States	Forest Investigative Site 041	Plano	Texas
United States	Forest Investigative Site 060	Richmond	Virginia
United States	Forest Investigative Site 057	Rochester	New York
United States	Forest Investigative Site 024	Rochester Hills	Michigan
United States	Forest Investigative Site 049	Rockville	Maryland
United States	Forest Investigative Site 030	Roswell	Georgia
United States	Forest Investigative Site 055	Saint Charles	Missouri
United States	Forest Investigative Site 072	Saint Louis	Missouri
United States	Forest Investigative Site 037	San Diego	California
United States	Forest Investigative Site 051	Terre Haute	Indiana
United States	Forest Investigative Site 045	The Woodlands	Texas
United States	Forest Investigative Site 065	Tulsa	Oklahoma
United States	Forest Investigative Site 006	Washington	District of Columbia
United States	Forest Investigative Site 026	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score	The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.	From Baseline to week 8
Secondary	Change in Clinical Global Impressions-Severity (CGI-S) Score	The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.	From Baseline to Week 8