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.
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
;
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