Phase 3
Completed N=529
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT01878292 ↗Enrolled (actual)
529
Serious AEs
1.1%
Results posted
Dec 2019
Primary outcomePrimary: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score — -22.48; -22.94; -24.22 units on a scale
◆ Published Evidence
Established
33citations · ~4 / year
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder.
Summary
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.
Linked Publications
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A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score |
-22.48; -22.94; -24.22 | — |
| SECONDARY Change in Clinical Global Impressions-Severity (CGI-S) Score |
-1.60; -1.82; -1.87 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01878292) and the linked publication. 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.