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
Age
19–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Vortioxetine for Treatment of Depressive Mood and Alcohol Use
