Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Vilazodone

• Registration Number: NCT01878292
• Lead Sponsor: Forest Laboratories

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-14
• Study Start: 2013-07-11
• Primary Completion: 2016-03-17
• Study Completion: 2016-10-05
• Status Verified: 2019-12
• Results First Submitted: 2019-12-06
• Results First Submitted QC: 2019-12-06
• Last Update Submitted: 2019-12-06
• Results First Posted: 2019-12-24
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 529

Inclusion Criteria

• Male or Female outpatients between 12-17 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dose-matched placebo tablets, once per day, oral administration
vilazodone 30 mg	Vilazodone	30 mg vilazodone tablets, once per day, oral administration
Vilazodone 15 mg	Vilazodone	15 mg vilazodone tablets, once per day, oral administration

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 (52)

Forest Investigative Site 073; 🇺🇸 Imperial, California, United States

Forest Investigative Site 052; 🇺🇸 Los Angeles, California, United States

Forest Investigative Site 023; 🇺🇸 Murrieta, California, United States

Forest Investigative Site 004; 🇺🇸 Orange, California, United States

Forest Investigative Site 037; 🇺🇸 San Diego, California, United States

Forest Investigative Site 006; 🇺🇸 Washington, District of Columbia, United States

Forest Investigative Site 039; 🇺🇸 Gainesville, Florida, United States

Forest Investigative Site 009; 🇺🇸 Jacksonville Beach, Florida, United States

Forest Investigative Site 063; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 034; 🇺🇸 Oakland Park, Florida, United States

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