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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02372799 |
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Date of registration:
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21/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
VLZ-MD-22 |
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Scientific 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 |
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Date of first enrolment:
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February 28, 2015 |
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Target sample size:
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473 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02372799 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Emily McCusker, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Forest Research Institute, an affiliate of Allergan plc. |
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Key inclusion & exclusion 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
Age minimum:
7 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Intervention(s)
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Drug: Vilazodone
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Drug: Fluoxetine
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Drug: Placebo
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Primary Outcome(s)
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Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
[Time Frame: From Baseline to Week 8]
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Secondary Outcome(s)
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Change in Clinical Global Impressions-Severity (CGI-S) Score
[Time Frame: From Baseline to Week 8]
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Secondary ID(s)
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VLZ-MD-22
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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