drugset / Trial / NCT02372799
Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2015-02-28
- Primary completion
- 2018-09-11
- Completion
- 2018-09-11
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Vilazodone; p = 0.7662; LSMD -0.40 (95% CI -3.08 to 2.27); MMRM NCT02372799 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluoxetine | Small molecule | 10 mg | Oral |
| Comparator | Fluoxetine | Small molecule | 20 mg | Oral |
| Subject | Vilazodone | Small molecule | 5 mg | Oral |
| Subject | Vilazodone | Small molecule | 10 mg | Oral |
| Subject | Vilazodone | Small molecule | 20 mg | Oral |