A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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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).

Official Title
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An Open-label Long-term Safety Study 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


Participation Criteria
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Eligibility Criteria
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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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vilazodone<br> | Drug: Vilazodone<br>* Vilazodone tablets, once daily, oral administration<br>* Other names: Viibryd;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE) | The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period | Visit 1 (Week -1) to up to Visit 16 (Week 26) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the 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. | Baseline (Week 0) to Week 26 | 
| Change From Baseline in the 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. | Baseline (Week 0) to Week 26 | 
| Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) | The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse. | Baseline (Week 0) to Week 26 |