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A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-23)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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

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

Inclusion Criteria:

  • Male or Female outpatients betw een 7-17 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, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment (de novo patients only)
  • History of suicidal behavior, or requires precaution against suicide
  • Not generally healthy medical condition
  • Seizure disorder

Sites / Locations

  • Alliance Clinical Research
  • Harmonex Neuroscience Research
  • Phoenix Children's Hospital
  • Woodland International Research Group, INC
  • CITrials - Bellflower
  • ATP Clinical Research
  • Behavioral Research Specialists, LLC
  • PCSD - Feighner Research
  • Pacific Clinical Research Medical Group
  • Children's National Medical Center
  • Palm Springs Research, LLC
  • IMIC Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Innovative Clinical Research, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Institute for Advanced Medical Research
  • Atlantic Center for Medical Research
  • Northwest Behavioral Research Center
  • Capstone Clinical Research
  • Baber Research Group
  • Neuroscience Research Institute Inc.
  • Psychiatric Associates
  • Lake Charles Clinical Trials
  • Hugo W Moser Research Institute at Kennedy Krieger, Inc.
  • Pharmsite Research Inc.
  • NeuroScientific Insights
  • Baystate Medical Center
  • Adams Clinical Trials, LLC
  • Millennium Psychiatric Associates
  • St. Charles Psychiatric Associates - Midwest Research Group
  • Erie County Medical Center/State University of New York of Buffalo Affiliate
  • BioScience Research LLC
  • Manhattan Behavioral Medicine
  • Finger Lakes Clinical research
  • Richmond Behavioral Associates
  • Haidar Almhana Nieding LLC
  • Neuro-Behavioral Clinical Research, Inc
  • University of Cincinnati
  • University Hospitals Cleveland Medical Center, Psychiatr
  • Ohio State Univ. Dept of Psychiatry
  • Professional Psychiatric Services
  • IPS Research Company
  • Cutting Edge Research Group
  • Research Strategies of Memphis LLC
  • BioBehavioral Research of Austin, PC
  • UT Health Science Center at Houston
  • Houston Endoscopy and Research Ctr
  • Research Across America
  • Focus and Balance
  • Family Psychiatry of The Woodlands
  • Ericksen Research and Development
  • UVA Center for Psychopharmacology Research in Youth
  • Northwest Clinical Research Center
  • Core Clinical Research
  • Okanagan Clinical Trials Inc.
  • Paediatric Sleep Research Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vilazodone

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period

Secondary Outcome Measures

Change From Baseline in the 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.
Change From Baseline in the 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.
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse.

Full Information

First Posted
April 28, 2015
Last Updated
September 10, 2019
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT02436239
Brief Title
A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Acronym
VLZ-MD-23
Official Title
An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2015 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
July 23, 2018 (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 long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vilazodone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Viibryd
Intervention Description
Vilazodone tablets, once daily, oral administration
Primary Outcome Measure Information:
Title
Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
Description
The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period
Time Frame
Visit 1 (Week -1) to up to Visit 16 (Week 26)
Secondary Outcome Measure Information:
Title
Change From Baseline in the 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
Baseline (Week 0) to Week 26
Title
Change From Baseline in the 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
Baseline (Week 0) to Week 26
Title
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
Description
The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse.
Time Frame
Baseline (Week 0) to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female outpatients betw een 7-17 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, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment (de novo patients only) 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
Emily McCusker, PhD
Organizational Affiliation
Forest Research Institute, Inc., an affiliate of Allergan, plc
Official's Role
Study Director
Facility Information:
Facility Name
Alliance Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Harmonex Neuroscience Research
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Woodland International Research Group, INC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
CITrials - Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
ATP Clinical Research
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
PCSD - Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Palm Springs Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
IMIC Inc.
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Institute for Advanced Medical Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Atlantic Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Baber Research Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Neuroscience Research Institute Inc.
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60301
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Hugo W Moser Research Institute at Kennedy Krieger, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Pharmsite Research Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
NeuroScientific Insights
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Adams Clinical Trials, LLC
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Millennium Psychiatric Associates
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. Charles Psychiatric Associates - Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Erie County Medical Center/State University of New York of Buffalo Affiliate
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
BioScience Research LLC
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Finger Lakes Clinical research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Haidar Almhana Nieding LLC
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Cleveland Medical Center, Psychiatr
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State Univ. Dept of Psychiatry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Professional Psychiatric Services
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Research Strategies of Memphis LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
BioBehavioral Research of Austin, PC
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
UT Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Houston Endoscopy and Research Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Focus and Balance
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Family Psychiatry of The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Ericksen Research and Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
UVA Center for Psychopharmacology Research in Youth
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Core Clinical Research
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Okanagan Clinical Trials Inc.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y1Z9
Country
Canada
Facility Name
Paediatric Sleep Research Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J3S3
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

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