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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Vilazodone
* Drug: Placebo
* Drug: Fluoxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vilazodone<br>Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day. | Drug: Vilazodone<br> <br> * Other names: Viibryd;|
| Placebo Comparator: Placebo<br>Dose-matched placebo tablets or capsules, oral administration, once per day. | Drug: Placebo<br> <br> |
| Active Comparator: Fluoxetine<br>Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day. | Drug: Fluoxetine<br> <br> * Other names: Prozac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score | The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. | From Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Global Impressions-Severity (CGI-S) Score | The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients. | From Baseline to Week 8 |