drugset / Trial / NCT04498897
Vortioxetine for Treatment of Depressive Mood and Alcohol Use
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blinded, placebo-controlled, multicenter study. A total of 128 subjects will be randomly assigned to a test group or placebo group in a 1:1 ratio. Subjects will receive vortioxetine (or placebo) and acamprosate for 6 weeks according to the treatment group. Four visits will be made (weeks 0, 2, 4, 8), and on visit 2-4 (weeks 2, 4, 8) compliance, depression symptoms, and alcohol craving will be assessed.
Timeline
- Start
- 2019-01-25
- Primary completion
- 2021-04-04
- Completion
- 2021-04-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Vortioxetine | Unknown | 5 mg | — |
| Comparator | Vortioxetine | Unknown | 10 mg | — |
| Comparator | Vortioxetine | Unknown | 20 mg | — |
| Comparator | Acamprosate | Small molecule | 666 mg | — |