Vortioxetine for Treatment of Depressive Mood and Alcohol Use

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Depressive Disorder, Major, Alcoholism

Intervention / Treatment
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* Drug: Vortioxetine
* Drug: Acamprosate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, placebo-controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test group<br>Vortioxetine + Acamprosate | Drug: Vortioxetine<br>* Baseline: Vortioxetine 10mg (or placebo) + Acamprosate First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate<br>Drug: Acamprosate<br>* Baseline: Vortioxetine 10mg (or placebo) + Acamprosate First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate<br>|
| Placebo Comparator: Placebo Group<br>Placebo + Acamprosate | Drug: Acamprosate<br>* Baseline: Vortioxetine 10mg (or placebo) + Acamprosate First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| K-MADRS | Korean-Version of the Montgomery-Asberg Depression Rating Scale | From baseline for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCDS-K | Korean version of the Obsessive Compulsive Drinking Scale | from baseline for 8 weeks |