Clinical trial NCT02436239: A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Official title: An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 330
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
timeFrame: Visit 1 (Week -1) to up to Visit 16 (Week 26)
Secondary outcomes:
measure: Change From Baseline in the CDRS-R Total Score
timeFrame: Baseline (Week 0) to Week 26
measure: Change From Baseline in the CGI-S Score
timeFrame: Baseline (Week 0) to Week 26
measure: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
timeFrame: Baseline (Week 0) to Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alliance Clinical Research
state: Alabama
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group, INC
state: Arkansas
city: Bellflower
country: United States
facility: CITrials - Bellflower
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: San Diego
country: United States
facility: PCSD - Feighner Research
state: California
city: Hartford
country: United States
facility: Pacific Clinical Research Medical Group
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Hialeah
country: United States
facility: Palm Springs Research, LLC
state: Florida
city: Homestead
country: United States
facility: IMIC Inc.
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Alpharetta
country: United States
facility: Institute for Advanced Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlantic Center for Medical Research
state: Georgia
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group
state: Illinois
city: Oak Park
country: United States
facility: Neuroscience Research Institute Inc.
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Baltimore
country: United States
facility: Hugo W Moser Research Institute at Kennedy Krieger, Inc.
state: Maryland
city: Baltimore
country: United States
facility: Pharmsite Research Inc.
state: Maryland
city: Rockville
country: United States
facility: NeuroScientific Insights
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical Trials, LLC
state: Massachusetts
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates
state: Missouri
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Buffalo
country: United States
facility: Erie County Medical Center/State University of New York of Buffalo Affiliate
state: New York
city: Mount Kisco
country: United States
facility: BioScience Research LLC
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Avon Lake
country: United States
facility: Haidar Almhana Nieding LLC
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Psychiatr
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ. Dept of Psychiatry
state: Ohio
city: Mason
country: United States
facility: Professional Psychiatric Services
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Memphis
country: United States
facility: Research Strategies of Memphis LLC
state: Tennessee
city: Austin
country: United States
facility: BioBehavioral Research of Austin, PC
state: Texas
city: Houston
country: United States
facility: UT Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Houston Endoscopy and Research Ctr
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Focus and Balance
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Charlottesville
country: United States
facility: UVA Center for Psychopharmacology Research in Youth
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kirkland
country: United States
facility: Core Clinical Research
state: Washington
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials Inc.
state: British Columbia
city: Toronto
country: Canada
facility: Paediatric Sleep Research Inc
state: Ontario
Study officials:
affiliation: Forest Research Institute, Inc., an affiliate of Allergan, plc
name: Emily McCusker, PhD
role: STUDY_DIRECTOR
References: