• Siegfried Kasper, Göran Hajak, Katharina Wulff, Witte J G Hoogendijk, Angel Luis Montejo, Enrico Smeraldi, Janusz K Rybakowski, Maria-Antonia Quera-Salva, Anna M Wirz-Justice, Françoise Picarel-Blanchot, and Franck J Baylé.
• Department of Psychiatry and Psychotherapy, Medical University Vienna, MUV, AKH, Währinger Gürtel 18-20, A-1090 Wien, Austria. biol-psychiatry@meduniwien.ac.at
• J Clin Psychiatry. 2010 Feb 1; 71 (2): 109-20.

ObjectiveThis study evaluates the efficacy of agomelatine, the first antidepressant to be an agonist at MT(1)/MT(2) receptors and an antagonist at 5-HT(2C) receptors, versus sertraline with regard to the amplitude of the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder (MDD).MethodOutpatients with DSM-IV-TR-defined MDD received either agomelatine 25 to 50 mg (n = 154) or sertraline 50 to 100 mg (n = 159) during a 6-week, randomized, double-blind treatment period. The study was conducted from 2005 to 2006. The main outcome measure was the relative amplitude of the individual rest-activity cycles, expressed as change from baseline to week 6 and collected from continuous records using wrist actigraphy and sleep logs. Secondary outcome measures were sleep efficiency and sleep latency, both derived from actigraphy, and efficacy on depression symptoms (17-Item Hamilton Depression Rating Scale total score and Clinical Global Impressions scale scores) and anxiety symptoms (Hamilton Anxiety Rating Scale total score and subscores).ResultsA significant difference in favor of agomelatine compared to sertraline on the relative amplitude of the circadian rest-activity cycle was observed at the end of the first week (P = .01). In parallel, a significant improvement of sleep latency (P <.001) and sleep efficiency (P <.001) from week 1 to week 6 was observed with agomelatine as compared to sertraline. Over the 6-week treatment period, depressive symptoms improved significantly more with agomelatine than with sertraline (P <.05), as did anxiety symptoms (P <.05).ConclusionsThe favorable effect of agomelatine on the relative amplitude of the circadian rest-activity/sleep-wake cycle in depressed patients at week 1 reflects early improvement in sleep and daytime functioning. Higher efficacy results were observed with agomelatine as compared to sertraline on both depressive and anxiety symptoms over the 6-week treatment period, together with a good tolerability profile. These findings indicate that agomelatine offers promising benefits for MDD patients.Trial Registrationwww.isrctn.org: ISRCTN49376288.Copyright 2010 Physicians Postgraduate Press, Inc.

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