Status:
UNKNOWN
Vortioxetine for Treatment of Depressive Mood and Alcohol Use
Lead Sponsor:
Hanyang University Seoul Hospital
Conditions:
Depressive Disorder, Major
Alcoholism
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
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 vo...
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 place...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 4 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04498897
Start Date
January 25 2019
End Date
April 4 2021
Last Update
August 5 2020
Active Locations (1)
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1
Hanyang USH
Seoul, South Korea