A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Status: | Completed |
---|---|
Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 7 - 17 |
Updated: | 10/25/2018 |
Start Date: | May 2, 2015 |
End Date: | July 23, 2018 |
An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
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).
for the treatment of MDD in pediatric outpatients (7-17 years).
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
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Buffalo, New York 14215
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405 Emmet Street South
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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