A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
- Registration Number
- NCT02436239
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vilazodone Vilazodone -
- Primary Outcome Measures
Name Time Method Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE) 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
Name Time Method Change From Baseline in the CDRS-R Total Score 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.
Change From Baseline in the CGI-S Score 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.
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) 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.
Trial Locations
- Locations (55)
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
Pharmsite Research Inc.
🇺🇸Baltimore, Maryland, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
University Hospitals Cleveland Medical Center, Psychiatr
🇺🇸Cleveland, Ohio, United States
Research Across America
🇺🇸Plano, Texas, United States
Palm Springs Research, LLC
🇺🇸Hialeah, Florida, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸Canton, Ohio, United States
NeuroScientific Insights
🇺🇸Rockville, Maryland, United States
St. Charles Psychiatric Associates - Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Institute for Advanced Medical Research
🇺🇸Alpharetta, Georgia, United States
Finger Lakes Clinical research
🇺🇸Rochester, New York, United States
IMIC Inc.
🇺🇸Homestead, Florida, United States
Manhattan Behavioral Medicine
🇺🇸New York, New York, United States
Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States
Ericksen Research and Development
🇺🇸Clinton, Utah, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Hugo W Moser Research Institute at Kennedy Krieger, Inc.
🇺🇸Baltimore, Maryland, United States
Haidar Almhana Nieding LLC
🇺🇸Avon Lake, Ohio, United States
Professional Psychiatric Services
🇺🇸Mason, Ohio, United States
Atlantic Center for Medical Research
🇺🇸Atlanta, Georgia, United States
BioScience Research LLC
🇺🇸Mount Kisco, New York, United States
Ohio State Univ. Dept of Psychiatry
🇺🇸Columbus, Ohio, United States
Family Psychiatry of The Woodlands
🇺🇸The Woodlands, Texas, United States
Millennium Psychiatric Associates
🇺🇸Creve Coeur, Missouri, United States
Paediatric Sleep Research Inc
🇨🇦Toronto, Ontario, Canada
UT Health Science Center at Houston
🇺🇸Houston, Texas, 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
Woodland International Research Group, INC
🇺🇸Little Rock, Arkansas, United States
CITrials - Bellflower
🇺🇸Bellflower, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
PCSD - Feighner Research
🇺🇸San Diego, California, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Pacific Clinical Research Medical Group
🇺🇸Hartford, Connecticut, United States
Research Strategies of Memphis LLC
🇺🇸Memphis, Tennessee, United States
Okanagan Clinical Trials Inc.
🇨🇦Kelowna, British Columbia, Canada
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Baber Research Group
🇺🇸Naperville, Illinois, United States
UVA Center for Psychopharmacology Research in Youth
🇺🇸Charlottesville, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Core Clinical Research
🇺🇸Kirkland, Washington, United States
Neuroscience Research Institute Inc.
🇺🇸Oak Park, Illinois, United States
Focus and Balance
🇺🇸San Antonio, Texas, United States
Houston Endoscopy and Research Ctr
🇺🇸Houston, Texas, United States
Adams Clinical Trials, LLC
🇺🇸Watertown, Massachusetts, United States
Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
BioBehavioral Research of Austin, PC
🇺🇸Austin, Texas, United States
Erie County Medical Center/State University of New York of Buffalo Affiliate
🇺🇸Buffalo, New York, United States