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

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.

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

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