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

An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Vilazodone

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vilazodone	Drug: Vilazodone; Vilazodone tablets, once daily, oral administration; Other Names: Viibryd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Visit 1 (Week -1) to up to Visit 16 (Week 26)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Week 0) to Week 26
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.	Baseline (Week 0) to Week 26
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.	Baseline (Week 0) to Week 26

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: Emily McCusker, PhD, Forest Research Institute, Inc., an affiliate of Allergan, plc

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2015
• Primary Completion (Actual): July 23, 2018
• Study Completion (Actual): July 23, 2018

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: May 1, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vilazodone Hydrochloride
• Other Study ID Numbers: VLZ-MD-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No