Vortioxetine for Treatment of Depressive Mood and Alcohol Use

Phase 2

• Conditions: Alcoholism; Depressive Disorder, Major
• Interventions: Drug: Vortioxetine; Drug: Acamprosate

• Registration Number: NCT04498897
• Lead Sponsor: Hanyang University Seoul Hospital

Brief 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

Study Timeline

• Study Start: 2019-01-25
• Status Verified: 2020-07
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Last Update Submitted: 2020-07-30
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05
• Primary Completion: 2021-04-04
• Study Completion: 2021-04-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Subjects who are able to understand the study and comply with all study procedures and willing to provide written informed consent prior to screening
• Male and female subjects aged 19 to 65 years old
• Diagnosed to have major depressive disorder and alcohol use disorder based on DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 by two separate psychiatrists.
• MADRS(Montgomery Åsberg Depression Rating Scale) ≥ 26 at baseline

Exclusion Criteria

• Subjects considered not safe to participate in the study (e.g. who has suicidal thoughts)
• Pregnant or breastfeeding
• Subjects with serious or unstable disease
• Clinical or laboratory signs of on-going hypothyroidism
• History of organic mental disorder, schizophrenia spectrum disorder, bipolar disorder, or substance abuse within 12 months (except for alcohol or nicotine abuse)
• Administration of antidepressant (MAOIs, SSRIs, SNRIs, TCAs) including vortioxetine and anti-craving medications (acamprosate, naltrexone) within 2 weeks from screening
• Administration of antipsychotic, anti-manic drugs, dopamine antagonists, anxiolytics (zolpidem more than 10mg, Benzodiazepine lorazepam equivalent dosage more than 2mg or used as alcohol withdrawal treatment) within 2 weeks from screening
• Administration of anti-depressant, fluoxetine, within 5 weeks from screening
• Subjects in need of an alcohol detoxification treatment
• Subjects in need of a hospitalization care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Vortioxetine	Vortioxetine + Acamprosate
Test group	Acamprosate	Vortioxetine + Acamprosate
Placebo Group	Acamprosate	Placebo + Acamprosate

Primary Outcome Measures

Name	Time	Method
K-MADRS	From baseline for 8 weeks	Korean-Version of the Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures

Name	Time	Method
OCDS-K	from baseline for 8 weeks	Korean version of the Obsessive Compulsive Drinking Scale

Trial Locations

Locations (1)

Hanyang USH; 🇰🇷 Seoul, Korea, Republic of