Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22) (VLZ-MD-22)
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|ClinicalTrials.gov Identifier: NCT02372799|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Vilazodone Drug: Placebo Drug: Fluoxetine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||473 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||February 28, 2015|
|Actual Primary Completion Date :||September 11, 2018|
|Actual Study Completion Date :||September 11, 2018|
Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
Other Name: Viibryd
Placebo Comparator: Placebo
Dose-matched placebo tablets or capsules, oral administration, once per day.
Active Comparator: Fluoxetine
Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.
Other Name: Prozac
- Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score [ Time Frame: From Baseline to Week 8 ]
- Change in Clinical Global Impressions-Severity (CGI-S) Score [ Time Frame: From Baseline to Week 8 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372799
Show 60 Study Locations
|Study Director:||Emily McCusker, PhD||Forest Research Institute, an affiliate of Allergan plc.|