Alcoholism, Depressive Disorder, Major
Conditions
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
Interventions
DRUGVortioxetine
* Baseline: Vortioxetine 10mg (or placebo) + Acamprosate * First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate * Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate
DRUGAcamprosate
* 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
Hanyang University Seoul Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded study
Intervention model description
A randomized, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| K-MADRS | From baseline for 8 weeks | Korean-Version of the Montgomery-Asberg Depression Rating Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OCDS-K | from baseline for 8 weeks | Korean version of the Obsessive Compulsive Drinking Scale |
Countries
South Korea
Contacts
Backup ContactSungwon Roh
Primary ContactJi-eun Kim
Outcome results
None listed