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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Vilazodone; Drug: Fluoxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02372799

VLZ-MD-22

Details and patient eligibility

About

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.

Enrollment: 473 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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473 participants in 3 patient groups, including a placebo group

Vilazodone

Experimental group

Description:

Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.

Treatment:

Drug: Vilazodone

Placebo

Placebo Comparator group

Description:

Dose-matched placebo tablets or capsules, oral administration, once per day.

Treatment:

Drug: Placebo

Fluoxetine

Active Comparator group

Description:

Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.

Treatment:

Drug: Fluoxetine