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Evid Based Mental Health 15:2-3 doi:10.1136/ebmh.2011.100485
  • EBMH Notebook

Agomelatine and the brave old world of narrative-based medicine

  1. Andrea Cipriani
  1. Department of Public Health and Community Medicine, Section of Psychiatry and Clinical Psychology, University of Verona, Italy
  1. Correspondence to Professor Corrado Barbui, Department of Public Health and Community Medicine, Section of Psychiatry and Clinical Psychology, University of Verona, Policlinico “G.B. Rossi”, Piazzale L.A. Scuro, 10 – 37134 Verona, Italy; corrado.barbui{at}univr.it

Introduction

Recent advances in understanding the links between chronobiology and major depression have led to the development of new drugs that target the circadian system. One of these drugs, agomelatine, has been recently the focus of several scientific reports describing its new mechanism of action and potential clinical role in major depression, including reports published in high reputation and impact factor journals.1,,5 We note that these scientific reports, despite being focused on new biological mechanisms, extensively presented and reviewed clinical trial data on agomelatine efficacy and safety, making strong claims of efficacy in favour of this new drug. This essay aims at raising awareness on the need to set a standard for reporting clinical data in articles dealing with basic science issues.

Claims of efficacy in review articles on the pharmacology of agomelatine

The most recent review article on the pharmacology of agomelatine was published by Hickie and Rogers.3 In this report, a table summarised the placebo-controlled and active comparator trials of agomelatine in individuals with major depression, and in the accompanying text it is clearly stated that agomelatine has clinically significant antidepressant properties. It is reported that it is more effective in patients with more severe depression, and that agomelatine is similarly effective in comparison with some comparator antidepressants, and is more effective than fluoxetine. In terms of tolerability, Hickie and Rogers reported a safe profile, and concluded that agomelatine might occupy a unique place in the management of some patients with severe depression. De Bodinat et al, who recently described the discovery and development of agomelatine, reported that agomelatine has shown to be effective in comparison with placebo and with other antidepressants, and has relapse prevention effect compared with placebo, with a good tolerability profile 2. Similarly, Arendt and Rajaratnam reported that clinical trials confirmed the efficacy and tolerability of agomelatine in …