NCT04498897

Vortioxetine for Treatment of Depressive Mood and Alcohol Use

A Randomized, Double-Blind, Placebo-Controlled Trial of Vortioxetine for Depressive Mood and Alcohol Use in Adults With Major Depressive Disorder and Alcohol Use Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Hanyang University Seoul Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Investigational product * baseline: Vortioxetine 10mg (or placebo) qd + Acamprosate\* * First 2 weeks: Vortioxetine 5-10mg (or placebo) qd+ Acamprosate\* * Last 6 weeks: Vortioxetine 5-20mg (or placebo) qd + Acamprosate\* * Acamprosate 666 mg bid for bodyweight \< 60 kg; Acamprosate 666 mg tid for bodyweight ≥ 60 kg

Conditions

• Depressive Disorder, Major
• Alcoholism

Interventions

Type	Name	Description
DRUG	Vortioxetine	* Baseline: Vortioxetine 10mg (or placebo) + Acamprosate * First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate * Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate
DRUG	Acamprosate	* Baseline: Vortioxetine 10mg (or placebo) + Acamprosate * First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate * Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate

Timeline

• Start date: 2019-01-25
• Primary completion: 2021-04-04
• Completion: 2021-04-04
• First posted: 2020-08-05
• Last updated: 2020-08-05

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study