Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
VLZ-MD-21
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
1 other identifier
interventional
529
1 country
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 major-depressive-disorder
Started Jul 2013
Longer than P75 for phase_3 major-depressive-disorder
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedStudy Start
First participant enrolled
July 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2016
CompletedResults Posted
Study results publicly available
December 24, 2019
CompletedDecember 24, 2019
December 1, 2019
2.7 years
June 11, 2013
December 6, 2019
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in Clinical Global Impressions-Severity (CGI-S) Score
From Baseline to Week 8
Study Arms (3)
Placebo
PLACEBO COMPARATORDose-matched placebo tablets, once per day, oral administration
Vilazodone 15 mg
EXPERIMENTAL15 mg vilazodone tablets, once per day, oral administration
vilazodone 30 mg
EXPERIMENTAL30 mg vilazodone tablets, once per day, oral administration
Interventions
Vilazodone tablets, 15 mg per day, oral administration
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Forest Investigative Site 073
Imperial, California, 92251, United States
Forest Investigative Site 052
Los Angeles, California, 90027, United States
Forest Investigative Site 023
Murrieta, California, 92562, United States
Forest Investigative Site 004
Orange, California, 92868, United States
Forest Investigative Site 037
San Diego, California, 92108, United States
Forest Investigative Site 006
Washington D.C., District of Columbia, 20010, United States
Forest Investigative Site 039
Gainesville, Florida, 32607, United States
Forest Investigative Site 009
Jacksonville Beach, Florida, 32250, United States
Forest Investigative Site 063
Miami, Florida, 33155, United States
Forest Investigative Site 034
Oakland Park, Florida, 33334, United States
Forest Investigative Site 016
Orlando, Florida, 32803, United States
Forest Investigative Site 064
Orlando, Florida, 32806, United States
Forest Investigative Site 014
Atlanta, Georgia, 30308, United States
Forest Investigative Site 030
Roswell, Georgia, 30076, United States
Forest Investigative Site 032
Libertyville, Illinois, 60048, United States
Forest Investigative Site 048
Naperville, Illinois, 60563, United States
Forest Investigative Site 051
Terre Haute, Indiana, 47802, United States
Forest Investigative Site 013
Overland Park, Kansas, 66211, United States
Forest Investigative Site 070
Lake Charles, Louisiana, 70629, United States
Forest Investigative Site 050
Baltimore, Maryland, 21205, United States
Forest Investigative Site 054
Baltimore, Maryland, 21208, United States
Forest Investigative Site 049
Rockville, Maryland, 20852, United States
Forest Investigative Site 026
Watertown, Massachusetts, 02472, United States
Forest Investigative Site 024
Rochester Hills, Michigan, 48307, United States
Forest Investigative Site 015
Creve Coeur, Missouri, 63141, United States
Forest Investigative Site 055
Saint Charles, Missouri, 63304, United States
Forest Investigative Site 072
St Louis, Missouri, 63128, United States
Forest Investigative Site 066
Las Vegas, Nevada, 89128, United States
Forest Investigative Site 007
Cherry Hill, New Jersey, 08002, United States
Forest Investigative Site 071
Neptune City, New Jersey, 07752, United States
Forest Investigative Site 008
Albuquerque, New Mexico, 87109, United States
Forest Investigative Site 057
Rochester, New York, 14618, United States
Forest Investigative Site 059
Durham, North Carolina, 27705, United States
Forest Investigative Site 053
Avon Lake, Ohio, 44012, United States
Forest Investigative Site 021
Canton, Ohio, 44718, United States
Forest Investigative Site 012
Cincinnati, Ohio, 45219, United States
Forest Investigative Site 029
Columbus, Ohio, 43210, United States
Forest Investigative Site 018
Oklahoma City, Oklahoma, 73103, United States
Forest Investigative Site 011
Oklahoma City, Oklahoma, 73112, United States
Forest Investigative Site 065
Tulsa, Oklahoma, 74104, United States
Forest Investigative Site 040
Philadelphia, Pennsylvania, 19139, United States
Forest Investigative Site 074
Charleston, South Carolina, 29407, United States
Forest Investigative Site 062
Memphis, Tennessee, 38119, United States
Forest Investigative Site 001
Dallas, Texas, 75235, United States
Forest Investigative Site 027
Houston, Texas, 77098, United States
Forest Investigative Site 041
Plano, Texas, 75093, United States
Forest Investigative Site 045
The Woodlands, Texas, 77381, United States
Forest Investigative Site 019
Clinton, Utah, 84015, United States
Forest Investigative Site 060
Richmond, Virginia, 23230, United States
Forest Investigative Site 035
Bellevue, Washington, 98007, United States
Forest Investigative Site 068
Bothell, Washington, 98011, United States
Forest Investigative Site 022
Kirkland, Washington, 98033, United States
Related Publications (1)
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.
PMID: 29633166DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Chandran Prakash
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2013
First Posted
June 14, 2013
Study Start
July 11, 2013
Primary Completion
March 17, 2016
Study Completion
October 5, 2016
Last Updated
December 24, 2019
Results First Posted
December 24, 2019
Record last verified: 2019-12