Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder (VLZ-MD-21)

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Vilazodone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01878292

VLZ-MD-21

Details and patient eligibility

About

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.

Enrollment: 529 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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529 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Dose-matched placebo tablets, once per day, oral administration

Treatment:

Drug: Placebo

Vilazodone 15 mg

Experimental group

Description:

15 mg vilazodone tablets, once per day, oral administration

Treatment:

Drug: Vilazodone

Drug: Vilazodone

vilazodone 30 mg

Experimental group

Description:

30 mg vilazodone tablets, once per day, oral administration

Treatment:

Drug: Vilazodone

Drug: Vilazodone