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)
Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Woodland International Research Group, INC
🇺🇸Little Rock, Arkansas, United States
CITrials - Bellflower
🇺🇸Bellflower, California, United States
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
PCSD - Feighner Research
🇺🇸San Diego, California, United States
Pacific Clinical Research Medical Group
🇺🇸Hartford, Connecticut, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Scroll for more (45 remaining)Alliance Clinical Research🇺🇸Birmingham, Alabama, United States