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)
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
🇺🇸Upland, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
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