Effectiveness and tolerability of mirtazapine and amitriptyline in alcoholic patients with co-morbid depressive disorder: a randomized, double-blind study.

OBJECTIVE Studies indicate that serotoninergic and noradrenergic pathophysiological mechanisms may underlie both alcohol abuse/dependence and depressive disorder. The purpose of this study was to evaluate and compare the effectiveness and tolerability of two serotonergic and noradrenergic antidepressant drugs-mirtazapine and amitriptyline, for the treatment of patients with alcohol dependence co-morbid with depressive disorder in a randomized, double-blind treatment setting. METHODS Forty-four patients were included in the study. Twenty-four patients were randomized to mirtazapine and twenty to amitriptyline groups. Thirty-six of them completed the study. The 17-item Hamilton Depression Rating Scale (HDRS), the Spielberger State-Trait Anxiety Inventory (STAI) and alcohol craving questionnaire were used at baseline and, at days 7, 14, 28, 42, and 56 to estimate the effectiveness of the antidepressant treatment. Michigan Alcoholism Screening Test (MAST) was used in the assessment of alcohol dependence. The tolerability was assessed with the Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU). RESULTS There was significant improvement in HDRS and alcohol craving scores with both the drugs. However there were no statistical differences between treatment groups. Mirtazapine was tolerated better than amitriptyline treatment. CONCLUSIONS The treatment with either mirtazapine or amitriptyline resulted with the reduction of HDRS and craving scores. The side-effect profile of mirtazapine was relatively favorable in our study.