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Trial record 1 of 1 for:    NCT02436239
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A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-23)

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ClinicalTrials.gov Identifier: NCT02436239
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Vilazodone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Actual Study Start Date : May 2, 2015
Actual Primary Completion Date : July 23, 2018
Actual Study Completion Date : July 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vilazodone Drug: Vilazodone
Vilazodone tablets, once daily, oral administration
Other Name: Viibryd




Primary Outcome Measures :
  1. Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE) [ Time Frame: Visit 1 (Week -1) to up to Visit 16 (Week 26) ]
    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 :
  1. Change From Baseline in the CDRS-R Total Score [ Time Frame: Baseline (Week 0) to Week 26 ]
    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.

  2. Change From Baseline in the CGI-S Score [ Time Frame: Baseline (Week 0) to Week 26 ]
    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.

  3. Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Baseline (Week 0) to Week 26 ]
    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.



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436239


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Locations
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United States, Alabama
Alliance Clinical Research
Birmingham, Alabama, United States, 35213
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, Arkansas
Woodland International Research Group, INC
Little Rock, Arkansas, United States, 72211
United States, California
CITrials - Bellflower
Bellflower, California, United States, 90706
ATP Clinical Research
Costa Mesa, California, United States, 92626
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
PCSD - Feighner Research
San Diego, California, United States, 92108
United States, Connecticut
Pacific Clinical Research Medical Group
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Palm Springs Research, LLC
Hialeah, Florida, United States, 33012
IMIC Inc.
Homestead, Florida, United States, 33030
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States, 33319
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
United States, Georgia
Institute for Advanced Medical Research
Alpharetta, Georgia, United States, 30005
Atlantic Center for Medical Research
Atlanta, Georgia, United States, 30331
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
United States, Illinois
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
Baber Research Group
Naperville, Illinois, United States, 60563
Neuroscience Research Institute Inc.
Oak Park, Illinois, United States, 60301
United States, Kansas
Psychiatric Associates
Overland Park, Kansas, United States, 66211
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
United States, Maryland
Hugo W Moser Research Institute at Kennedy Krieger, Inc.
Baltimore, Maryland, United States, 21205
Pharmsite Research Inc.
Baltimore, Maryland, United States, 21208
NeuroScientific Insights
Rockville, Maryland, United States, 20852
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Adams Clinical Trials, LLC
Watertown, Massachusetts, United States, 02472
United States, Missouri
Millennium Psychiatric Associates
Creve Coeur, Missouri, United States, 63141
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States, 63304
United States, New York
Erie County Medical Center/State University of New York of Buffalo Affiliate
Buffalo, New York, United States, 14215
BioScience Research LLC
Mount Kisco, New York, United States, 10549
Manhattan Behavioral Medicine
New York, New York, United States, 10022
Finger Lakes Clinical research
Rochester, New York, United States, 14618
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, Ohio
Haidar Almhana Nieding LLC
Avon Lake, Ohio, United States, 44012
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, United States, 44718
University of Cincinnati
Cincinnati, Ohio, United States, 45219
University Hospitals Cleveland Medical Center, Psychiatr
Cleveland, Ohio, United States, 44106
Ohio State Univ. Dept of Psychiatry
Columbus, Ohio, United States, 43210
Professional Psychiatric Services
Mason, Ohio, United States, 45040
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73116
United States, Tennessee
Research Strategies of Memphis LLC
Memphis, Tennessee, United States, 38119
United States, Texas
BioBehavioral Research of Austin, PC
Austin, Texas, United States, 78759
UT Health Science Center at Houston
Houston, Texas, United States, 77054
Houston Endoscopy and Research Ctr
Houston, Texas, United States, 77079
Research Across America
Plano, Texas, United States, 75093
Focus and Balance
San Antonio, Texas, United States, 78229
Family Psychiatry of The Woodlands
The Woodlands, Texas, United States, 77381
United States, Utah
Ericksen Research and Development
Clinton, Utah, United States, 84015
United States, Virginia
UVA Center for Psychopharmacology Research in Youth
Charlottesville, Virginia, United States, 22903
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Core Clinical Research
Kirkland, Washington, United States, 98033
Canada, British Columbia
Okanagan Clinical Trials Inc.
Kelowna, British Columbia, Canada, V1Y1Z9
Canada, Ontario
Paediatric Sleep Research Inc
Toronto, Ontario, Canada, M6J3S3
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Emily McCusker, PhD Forest Research Institute, Inc., an affiliate of Allergan, plc
  Study Documents (Full-Text)

Documents provided by Forest Laboratories:
Study Protocol  [PDF] November 2, 2016
Statistical Analysis Plan  [PDF] February 10, 2016


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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02436239     History of Changes
Other Study ID Numbers: VLZ-MD-23
First Posted: May 6, 2015    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vilazodone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists