Phase 3 Completed N=330 Treatment

A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

Major Depressive Disorder

Source: ClinicalTrials.gov NCT02436239 ↗

Enrolled (actual)

330

Serious AEs

2.1%

Results posted

Sep 2019

Primary outcomePrimary: Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE) — 90; 89; 48; 10 Participants

◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)	90; 89; 48; 10	—
SECONDARY Change From Baseline in the CDRS-R Total Score	-29.2; -30.1; -29.4; -24.5	—
SECONDARY Change From Baseline in the CGI-S Score	-2.5; -2.6; -2.5; -1.7	—
SECONDARY Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)	2.1; 2.0; 2.0; 2.2	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02436239). 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.