Major Depressive Disorder Clinical Trial
— VLZ-MD-23Official title:
An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
NCT number | NCT02436239 |
Other study ID # | VLZ-MD-23 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2, 2015 |
Est. completion date | July 23, 2018 |
Verified date | September 2019 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 330 |
Est. completion date | July 23, 2018 |
Est. primary completion date | July 23, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Okanagan Clinical Trials Inc. | Kelowna | British Columbia |
Canada | Paediatric Sleep Research Inc | Toronto | Ontario |
United States | Institute for Advanced Medical Research | Alpharetta | Georgia |
United States | Atlantic Center for Medical Research | Atlanta | Georgia |
United States | BioBehavioral Research of Austin, PC | Austin | Texas |
United States | Haidar Almhana Nieding LLC | Avon Lake | Ohio |
United States | Hugo W Moser Research Institute at Kennedy Krieger, Inc. | Baltimore | Maryland |
United States | Pharmsite Research Inc. | Baltimore | Maryland |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | CITrials - Bellflower | Bellflower | California |
United States | Alliance Clinical Research | Birmingham | Alabama |
United States | Erie County Medical Center/State University of New York of Buffalo Affiliate | Buffalo | New York |
United States | Neuro-Behavioral Clinical Research, Inc | Canton | Ohio |
United States | UVA Center for Psychopharmacology Research in Youth | Charlottesville | Virginia |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | University Hospitals Cleveland Medical Center, Psychiatr | Cleveland | Ohio |
United States | Ericksen Research and Development | Clinton | Utah |
United States | Ohio State Univ. Dept of Psychiatry | Columbus | Ohio |
United States | ATP Clinical Research | Costa Mesa | California |
United States | Millennium Psychiatric Associates | Creve Coeur | Missouri |
United States | Harmonex Neuroscience Research | Dothan | Alabama |
United States | Behavioral Research Specialists, LLC | Glendale | California |
United States | Pacific Clinical Research Medical Group | Hartford | Connecticut |
United States | Palm Springs Research, LLC | Hialeah | Florida |
United States | IMIC Inc. | Homestead | Florida |
United States | Houston Endoscopy and Research Ctr | Houston | Texas |
United States | UT Health Science Center at Houston | Houston | Texas |
United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
United States | Core Clinical Research | Kirkland | Washington |
United States | Lake Charles Clinical Trials | Lake Charles | Louisiana |
United States | Innovative Clinical Research, Inc. | Lauderhill | Florida |
United States | Capstone Clinical Research | Libertyville | Illinois |
United States | Woodland International Research Group, INC | Little Rock | Arkansas |
United States | Northwest Behavioral Research Center | Marietta | Georgia |
United States | Professional Psychiatric Services | Mason | Ohio |
United States | Research Strategies of Memphis LLC | Memphis | Tennessee |
United States | BioScience Research LLC | Mount Kisco | New York |
United States | Baber Research Group | Naperville | Illinois |
United States | Manhattan Behavioral Medicine | New York | New York |
United States | Neuroscience Research Institute Inc. | Oak Park | Illinois |
United States | Cutting Edge Research Group | Oklahoma City | Oklahoma |
United States | IPS Research Company | Oklahoma City | Oklahoma |
United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
United States | Psychiatric Associates | Overland Park | Kansas |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Research Across America | Plano | Texas |
United States | Finger Lakes Clinical research | Rochester | New York |
United States | NeuroScientific Insights | Rockville | Maryland |
United States | St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri |
United States | Focus and Balance | San Antonio | Texas |
United States | PCSD - Feighner Research | San Diego | California |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | Richmond Behavioral Associates | Staten Island | New York |
United States | Family Psychiatry of The Woodlands | The Woodlands | Texas |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Adams Clinical Trials, LLC | Watertown | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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