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Original Research

The Efficacy of Agomelatine in Elderly Patients With Recurrent Major Depressive Disorder: A Placebo-Controlled Study

Reinhard Heun, MD; Antti Ahokas, MD; Patrice Boyer, MD; Natalia Giménez-Montesinos, PharmD; Fernando Pontes-Soares, MD, PhD; and Valérie Olivier, PharmD, PhD; on Behalf of the Agomelatine Study Group

Published: June 15, 2013

Article Abstract

Objective: The present placebo-controlled study evaluated the efficacy, tolerability, and safety of 8-week treatment with agomelatine (25-50 mg/d by mouth) in elderly patients with major depressive disorder (MDD).

Method: Elderly outpatients aged ≥ 65 years with a primary diagnosis of moderate to severe episode of recurrent MDD (DSM-IV-TR) were recruited in 27 clinical centers in Argentina, Finland, Mexico, Portugal, and Romania from November 2009 to October 2011. The primary outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS17) total score.

Results: A total of 222 elderly patients entered the study (151 in the agomelatine group, 71 in the placebo group), including 69 patients aged 75 years and older. Agomelatine improved depressive symptoms in the elderly population, as evaluated by the HDRS17 total score, in terms of last postbaseline value (agomelatine-placebo difference: mean estimate [standard error] = 2.67 [1.06] points; P = .013) and response to treatment (agomelatine, 59.5%; placebo, 38.6%; P = .004). The agomelatine-placebo difference according to the Clinical Global Impressions-Severity of Illness scale (CGI-S) score was 0.48 (0.19). The agomelatine-placebo difference (estimate [standard error]) for remission on the HDRS17 was 6.9% (4.7%) and did not achieve statistical significance (P = .179, post hoc analysis). Clinically relevant effects of agomelatine were confirmed on all end points in the subset of severely depressed patients (HDRS17 total score ≥ 25 and CGI-S score ≥ 5 at baseline). Agomelatine was well tolerated by patients, with only minimal distinctions from placebo.

Conclusions: The present study provides the first evidence that an 8-week treatment with agomelatine 25-50 mg/d efficiently relieves depressive symptoms and is well tolerated in elderly depressed patients older than 65 years.

Trial Registration: identifier: ISRCTN57507360

J Clin Psychiatry 2013;74(6):587-594

Submitted: October 29, 2012; accepted March 19, 2013 (doi:10.4088/JCP.12m08250).

Corresponding author: Reinhard Heun, MD, Radbourne Unit, Derby City General Hospital, Uttoxeter Rd, Derby DE22 3NE, United Kingdom (

Volume: 74

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