Comparable efficacy and safety of 8 weeks treatment with agomelatine 25-50 mg or fluoxetine 20-40 mg in Asian out-patients with major depressive disorder

Objective: This randomized, double-blind study evaluates the efficacy and tolerability of agomelatine, using fluoxetine as an active comparator, in Asian patients suffering from moderate to severe major depressive disorder (MDD). Method: Patients were randomly assigned to receive either agomelatine (25-50 mg/day, n = 314) or fluoxetine (20-40 mg/day, n = 314) during an 8-week treatment period. The main outcome measure was the change in Hamilton Depression Rating Scale 17 items (HAM-D-17) scores. Secondary efficacy criteria included scores on Clinical Global Impression Severity of illness (CGI-S) and Improvement of illness (CGI-I), patient sleeping improvement using the self-rating Leeds Sleep Evaluation Questionnaire (LSEQ) and anxiety using the Hamilton Anxiety Rating Scale (HAM-A) scores. Tolerability and safety evaluations were based on emergent adverse events. Results: Agomelatine and fluoxetine exert a comparable antidepressant efficacy in the Asian population. Mean changes over 8 weeks were clinically relevant and similar in both groups (-14.8 +/- 7.3 and - 15.0 +/- 8.1 on HAM-D-17 scale in agomelatine and fluoxetine groups, respectively). The between-group difference reached statistical significance on non-inferiority test (p = 0.015). Clinically relevant decreases in CGI-S and CGI-I scores were observed over the treatment period in both groups. The two treatments were equally effective on the symptoms of both anxiety and sleep. The good tolerability profile and safety of both doses of agomelatine was confirmed in the Asian population. Conclusions: Agomelatine and fluoxetine are equally effective in the treatment of MDD-associated symptoms in Asian depressed patients. (C) 2013 Elsevier B.V. All rights reserved.