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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
* Baseline: Vortioxetine 10mg (or placebo) + Acamprosate * First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate * Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate
* Baseline: Vortioxetine 10mg (or placebo) + Acamprosate * First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate * Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate
Hanyang USH
Seoul, South Korea
RECRUITINGK-MADRS
Korean-Version of the Montgomery-Asberg Depression Rating Scale
Time frame: From baseline for 8 weeks
OCDS-K
Korean version of the Obsessive Compulsive Drinking Scale
Time frame: from baseline for 8 weeks
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