Clinical trial NCT04498897: Vortioxetine for Treatment of Depressive Mood and Alcohol Use
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depressive Disorder, Major
Alcoholism
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 128
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, placebo-controlled study
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: K-MADRS
timeFrame: From baseline for 8 weeks
Secondary outcomes:
measure: OCDS-K
timeFrame: from baseline for 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang USH
Study officials:
affiliation: swroh@hanyang.ac.kr
name: Sungwon Roh
role: PRINCIPAL_INVESTIGATOR
References: