A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-23)

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Vilazodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02436239

VLZ-MD-23

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).

Enrollment: 330 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female outpatients betw een 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, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment (de novo patients only)
• History of suicidal behavior, or requires precaution against suicide
• Not generally healthy medical condition
• Seizure disorder

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

330 participants in 1 patient group

Vilazodone

Experimental group

Treatment:

Drug: Vilazodone