Phase 3 Completed N=470 Randomized Quadruple-blind Treatment

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

Major Depressive Disorder

Source: ClinicalTrials.gov NCT02372799 ↗

Enrolled (actual)

470

Serious AEs

1.5%

Results posted

Oct 2019

Primary outcomePrimary: Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score — -20.32; -20.72; -22.71 units on a scale — p=0.7662

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score	-20.32; -20.72; -22.71	0.7662
SECONDARY Change in Clinical Global Impressions-Severity (CGI-S) Score	-1.52; -1.57; -1.72	0.7387

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02372799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.