Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT02372799
- Lead Sponsor
- Forest Laboratories
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 473
- Male or Female outpatients between 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vilazodone Vilazodone Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day. Placebo Placebo Dose-matched placebo tablets or capsules, oral administration, once per day. Fluoxetine Fluoxetine Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.
- Primary Outcome Measures
Name Time Method Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score From Baseline to Week 8 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
Name Time Method Change in Clinical Global Impressions-Severity (CGI-S) Score From Baseline to Week 8 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.
Trial Locations
- Locations (59)
Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States
Woodland International Research Group, INC
🇺🇸Little Rock, Arkansas, United States
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
CITrials - Bellflower
🇺🇸Bellflower, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Palm Springs Research, LLC
🇺🇸Hialeah, Florida, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Osceola Mental Health dba Park Place Behavioral Health Care
🇺🇸Kissimmee, Florida, United States
IMIC Inc.
🇺🇸Homestead, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Institute for Advanced Medical Research
🇺🇸Alpharetta, Georgia, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Atlantic Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Baber Research Group
🇺🇸Naperville, Illinois, United States
Neuroscience Research Institute Inc.
🇺🇸Oak Park, Illinois, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
Hugo W Moser Research Institute at Kennedy Krieger, Inc.
🇺🇸Baltimore, Maryland, United States
Pharmsite Research Inc.
🇺🇸Baltimore, Maryland, United States
Millennium Psychiatric Associates
🇺🇸Creve Coeur, Missouri, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Adams Clinical Trials, LLC
🇺🇸Watertown, Massachusetts, United States
St. Charles Psychiatric Associates - Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Manhattan Behavioral Medicine
🇺🇸New York, New York, United States
Finger Lakes Clinical research
🇺🇸Rochester, New York, United States
BioScience Research LLC
🇺🇸Mount Kisco, New York, United States
Haidar Almhana Nieding LLC
🇺🇸Avon Lake, Ohio, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸Canton, Ohio, United States
University Hospitals Cleveland Medical Center, Psychiatry
🇺🇸Cleveland, Ohio, United States
Professional Psychiatric Services
🇺🇸Mason, Ohio, United States
Ohio State Univ. Dept of Psychiatry
🇺🇸Columbus, Ohio, United States
University of TX Southwestern Medical Ctr
🇺🇸Dallas, Texas, United States
Bayou City Research Ltd
🇺🇸Houston, Texas, United States
Houston Endoscopy and Research Ctr
🇺🇸Houston, Texas, United States
Research Across America
🇺🇸Plano, Texas, United States
Ericksen Research and Development
🇺🇸Clinton, Utah, United States
Family Psychiatry of The Woodlands
🇺🇸The Woodlands, Texas, United States
UVA Center for Psychopharmacology Research in Youth
🇺🇸Charlottesville, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
Core Clinical Research
🇺🇸Everett, Washington, United States
Paediatric Sleep Research Inc
🇨🇦Toronto, Ontario, Canada
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
PCSD - Feighner Research
🇺🇸San Diego, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Goldpoint Clinical Research, LLC
🇺🇸Indianapolis, Indiana, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
FutureSearch Clinical trials, Inc.
🇺🇸Austin, Texas, United States
BioBehavioral Research of Austin, PC
🇺🇸Austin, Texas, United States
Focus and Balance
🇺🇸San Antonio, Texas, United States
Research Strategies of Memphis LLC
🇺🇸Memphis, Tennessee, United States
NeuroScientific Insights
🇺🇸Rockville, Maryland, United States