Clinical trial NCT01878292: Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2013-06-14
Enrollment: 529
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
timeFrame: From Baseline to week 8
Secondary outcomes:
measure: Change in Clinical Global Impressions-Severity (CGI-S) Score
timeFrame: From Baseline to Week 8
Other outcomes:
Locations:
city: Imperial
country: United States
facility: Forest Investigative Site 073
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 052
state: California
city: Murrieta
country: United States
facility: Forest Investigative Site 023
state: California
city: Orange
country: United States
facility: Forest Investigative Site 004
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 037
state: California
city: Washington
country: United States
facility: Forest Investigative Site 006
state: District of Columbia
city: Gainesville
country: United States
facility: Forest Investigative Site 039
state: Florida
city: Jacksonville Beach
country: United States
facility: Forest Investigative Site 009
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 063
state: Florida
city: Oakland Park
country: United States
facility: Forest Investigative Site 034
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 016
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 064
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 014
state: Georgia
city: Roswell
country: United States
facility: Forest Investigative Site 030
state: Georgia
city: Libertyville
country: United States
facility: Forest Investigative Site 032
state: Illinois
city: Naperville
country: United States
facility: Forest Investigative Site 048
state: Illinois
city: Terre Haute
country: United States
facility: Forest Investigative Site 051
state: Indiana
city: Overland Park
country: United States
facility: Forest Investigative Site 013
state: Kansas
city: Lake Charles
country: United States
facility: Forest Investigative Site 070
state: Louisiana
city: Baltimore
country: United States
facility: Forest Investigative Site 050
state: Maryland
city: Baltimore
country: United States
facility: Forest Investigative Site 054
state: Maryland
city: Rockville
country: United States
facility: Forest Investigative Site 049
state: Maryland
city: Watertown
country: United States
facility: Forest Investigative Site 026
state: Massachusetts
city: Rochester Hills
country: United States
facility: Forest Investigative Site 024
state: Michigan
city: Creve Coeur
country: United States
facility: Forest Investigative Site 015
state: Missouri
city: Saint Charles
country: United States
facility: Forest Investigative Site 055
state: Missouri
city: Saint Louis
country: United States
facility: Forest Investigative Site 072
state: Missouri
city: Las Vegas
country: United States
facility: Forest Investigative Site 066
state: Nevada
city: Cherry Hill
country: United States
facility: Forest Investigative Site 007
state: New Jersey
city: Neptune
country: United States
facility: Forest Investigative Site 071
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 008
state: New Mexico
city: Rochester
country: United States
facility: Forest Investigative Site 057
state: New York
city: Durham
country: United States
facility: Forest Investigative Site 059
state: North Carolina
city: Avon Lake
country: United States
facility: Forest Investigative Site 053
state: Ohio
city: Canton
country: United States
facility: Forest Investigative Site 021
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 012
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 029
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 018
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 011
state: Oklahoma
city: Tulsa
country: United States
facility: Forest Investigative Site 065
state: Oklahoma
city: Philadelphia
country: United States
facility: Forest Investigative Site 040
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site 074
state: South Carolina
city: Memphis
country: United States
facility: Forest Investigative Site 062
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 001
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 027
state: Texas
city: Plano
country: United States
facility: Forest Investigative Site 041
state: Texas
city: The Woodlands
country: United States
facility: Forest Investigative Site 045
state: Texas
city: Clinton
country: United States
facility: Forest Investigative Site 019
state: Utah
city: Richmond
country: United States
facility: Forest Investigative Site 060
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site 035
state: Washington
city: Bothell
country: United States
facility: Forest Investigative Site 068
state: Washington
city: Kirkland
country: United States
facility: Forest Investigative Site 022
state: Washington
Study officials:
affiliation: Allergan
name: Chandran Prakash
role: STUDY_DIRECTOR
References:
citation: Durgam S, Chen C, Migliore R, Prakash C, Edwards J, Findling RL. A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder. Paediatr Drugs. 2018 Aug;20(4):353-363. doi: 10.1007/s40272-018-0290-4.