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Vortioxetine for Treatment of Depressive Mood and Alcohol Use

NCT04498897 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2020-08-05

No results posted yet for this study

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.

Conditions

  • Depressive Disorder, Major
  • Alcoholism

Interventions

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

Sponsors & Collaborators

  • Hanyang University Seoul Hospital

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2021-04-04
Completion
2021-04-04
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04498897 on ClinicalTrials.gov