drugset / Trial / NCT04498897

Vortioxetine for Treatment of Depressive Mood and Alcohol Use

NCT04498897

Phase 2 Unknown 128 enrolled Hanyang University Seoul Hospital
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

EvaluationDrugModalityDoseRoute
Comparator Vortioxetine Unknown 5 mg
Comparator Vortioxetine Unknown 10 mg
Comparator Vortioxetine Unknown 20 mg
Comparator Acamprosate Small molecule 666 mg