RESUMEN
AIM: The main objective of the study was the evaluation of therapeutic efficacy of tianeptine (T) (37.5 mg/day) in comparison with fluvoxamine (F) (100 mg/day) in depressed patients with alcohol dependence or harmful use who had abstained from alcohol, in a 6-week treatment period. The secondary objectives were the assessment of the acceptability of both drugs and analysis of the alcohol craving behaviour regarding both treatments. METHOD: Outpatients who met ICD-10 criteria for depression and alcohol dependence or harmful use were randomised to a double-blind 6-week comparative trail. Responders (50% or more reduction in baseline HDRS) were proposed to continue the same treatment up to 90 days. The antidepressant efficacy was assessed with the use of the HDRS (main criterion). Other scales used in the study were HARS, CGI and OCDS. Tolerance was evaluated by monitoring of adverse events. RESULTS: A total of 298 (150 in T group and 148 in F group) were randomized. Both drugs showed good efficacy in the treatment of depressive symptoms. In Full Analysis Set (FAS) mean HDRS score significantly decreased in both groups from 22.2 at baseline to 10.6 at end-point in T group and from 21.8 to 11.4 in F group. There was no statistical difference between groups. The number of patients found to be responders at end-point was 72.1% in the T group and 67.1% in the F group. There was significant improvement in both treatment groups in HARS and CGI. Also analysis of alcohol craving by the OCDS scale showed significant improvement in both groups. No significant difference between treatment groups regarding those scales was noted. In a 6-week treatment period, statistically significantly more patients continued the study in the T group. Tolerability of both drugs was good. 16.7% of the patients experienced at least one adverse event in the T group and 20.3% in the F group. CONCLUSION: Tianeptine and fluvoxamine are effective and safe in the treatment of depression in the group of patients with alcohol dependence.