Depressive Disorder, Major Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | April 4, 2021 |
Est. primary completion date | April 4, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hanyang USH | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hanyang University Seoul Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | K-MADRS | Korean-Version of the Montgomery-Asberg Depression Rating Scale | From baseline for 8 weeks | |
Secondary | OCDS-K | Korean version of the Obsessive Compulsive Drinking Scale | from baseline for 8 weeks |
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