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Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder (VLZ-MD-21)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Vilazodone
Vilazodone
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site 073
  • Forest Investigative Site 052
  • Forest Investigative Site 023
  • Forest Investigative Site 004
  • Forest Investigative Site 037
  • Forest Investigative Site 006
  • Forest Investigative Site 039
  • Forest Investigative Site 009
  • Forest Investigative Site 063
  • Forest Investigative Site 034
  • Forest Investigative Site 016
  • Forest Investigative Site 064
  • Forest Investigative Site 014
  • Forest Investigative Site 030
  • Forest Investigative Site 032
  • Forest Investigative Site 048
  • Forest Investigative Site 051
  • Forest Investigative Site 013
  • Forest Investigative Site 070
  • Forest Investigative Site 050
  • Forest Investigative Site 054
  • Forest Investigative Site 049
  • Forest Investigative Site 026
  • Forest Investigative Site 024
  • Forest Investigative Site 015
  • Forest Investigative Site 055
  • Forest Investigative Site 072
  • Forest Investigative Site 066
  • Forest Investigative Site 007
  • Forest Investigative Site 071
  • Forest Investigative Site 008
  • Forest Investigative Site 057
  • Forest Investigative Site 059
  • Forest Investigative Site 053
  • Forest Investigative Site 021
  • Forest Investigative Site 012
  • Forest Investigative Site 029
  • Forest Investigative Site 018
  • Forest Investigative Site 011
  • Forest Investigative Site 065
  • Forest Investigative Site 040
  • Forest Investigative Site 074
  • Forest Investigative Site 062
  • Forest Investigative Site 001
  • Forest Investigative Site 027
  • Forest Investigative Site 041
  • Forest Investigative Site 045
  • Forest Investigative Site 019
  • Forest Investigative Site 060
  • Forest Investigative Site 035
  • Forest Investigative Site 068
  • Forest Investigative Site 022

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Vilazodone 15 mg

vilazodone 30 mg

Arm Description

Dose-matched placebo tablets, once per day, oral administration

15 mg vilazodone tablets, once per day, oral administration

30 mg vilazodone tablets, once per day, oral administration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 11, 2013
Last Updated
December 6, 2019
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01878292
Brief Title
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 11, 2013 (Actual)
Primary Completion Date
March 17, 2016 (Actual)
Study Completion Date
October 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
529 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dose-matched placebo tablets, once per day, oral administration
Arm Title
Vilazodone 15 mg
Arm Type
Experimental
Arm Description
15 mg vilazodone tablets, once per day, oral administration
Arm Title
vilazodone 30 mg
Arm Type
Experimental
Arm Description
30 mg vilazodone tablets, once per day, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose matched placebo tablets, once per day, oral administration.
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Viibryd
Intervention Description
Vilazodone tablets, 15 mg per day, oral administration
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Viibryd
Intervention Description
Vilazodone tablets, 30 mg once per day, oral administration
Primary Outcome Measure Information:
Title
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Description
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.
Time Frame
From Baseline to week 8
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impressions-Severity (CGI-S) Score
Description
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.
Time Frame
From Baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandran Prakash
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 073
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Forest Investigative Site 052
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Forest Investigative Site 023
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Forest Investigative Site 004
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site 037
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Forest Investigative Site 006
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Forest Investigative Site 039
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Forest Investigative Site 009
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Forest Investigative Site 063
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Forest Investigative Site 034
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Forest Investigative Site 016
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Forest Investigative Site 064
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 014
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Forest Investigative Site 030
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Forest Investigative Site 032
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Forest Investigative Site 048
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Forest Investigative Site 051
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Forest Investigative Site 013
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Forest Investigative Site 070
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Forest Investigative Site 050
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Forest Investigative Site 054
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Forest Investigative Site 049
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Forest Investigative Site 026
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Forest Investigative Site 024
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Forest Investigative Site 015
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 055
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Forest Investigative Site 072
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Forest Investigative Site 066
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Forest Investigative Site 007
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 071
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07752
Country
United States
Facility Name
Forest Investigative Site 008
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Forest Investigative Site 057
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Forest Investigative Site 059
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Forest Investigative Site 053
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
Forest Investigative Site 021
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Forest Investigative Site 012
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 029
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Forest Investigative Site 018
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Forest Investigative Site 011
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 065
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Forest Investigative Site 040
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative Site 074
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Forest Investigative Site 062
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 001
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Forest Investigative Site 027
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Forest Investigative Site 041
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Forest Investigative Site 045
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Forest Investigative Site 019
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Forest Investigative Site 060
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Forest Investigative Site 035
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 068
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Forest Investigative Site 022
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29633166
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.
Results Reference
derived

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

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