Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
| 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: | February 28, 2015 |
| End Date: | September 11, 2018 |
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
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.
compared with placebo in pediatric outpatients (7-17 years of age) with major depressive
disorder.
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
We found this trial at
59
sites
111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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405 Emmet Street South
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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206 Park Place Boulevard
Kissimmee, Florida 34741
Kissimmee, Florida 34741
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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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Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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