Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)

Overview

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.

Full Title of Study: “A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 11, 2018

Interventions

  • Drug: Vilazodone
  • Drug: Placebo
  • Drug: Fluoxetine

Arms, Groups and Cohorts

  • Experimental: Vilazodone
    • Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
  • Placebo Comparator: Placebo
    • Dose-matched placebo tablets or capsules, oral administration, once per day.
  • Active Comparator: Fluoxetine
    • Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Children’s Depression Rating Scale-Revised (CDRS-R) Total Score
    • Time Frame: 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 Measures

  • Change in Clinical Global Impressions-Severity (CGI-S) Score
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Forest Laboratories
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Emily McCusker, PhD, Study Director, Forest Research Institute, an affiliate of Allergan plc.

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