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Agomelatine in the treatment of major depressive disorder

Potential for clinical effectiveness

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Abstract

To demonstrate the clinical effectiveness of an antidepressant drug requires evidence beyond short- and long-term efficacy, including a favourable adverse-effect profile and sustained treatment adherence. Under these conditions, patients should experience enhanced social and functional outcomes. The novel antidepressant agomelatine, a melatonergic MT1/MT2 receptor agonist with serotonin 5-HT2C receptor antagonist activity, displays antidepressant efficacy with a favourable adverse-effect profile that is associated with good patient adherence. Specifically, agomelatine has demonstrated significant short-term (6–8 weeks) and sustained (6 months) antidepressant efficacy relative to placebo, as well as evidence of relapse prevention (up to 10 months). In head-to-head comparative studies with venlafaxine and sertraline, there was evidence of early (at 1–2 weeks) and sustained (at 6 months) advantages for agomelatine. In addition to evidence of early efficacy, agomelatine also restored disturbed sleep-wake patterns early in treatment. There was no evidence of antidepressant-induced sexual dysfunction, weight gain or discontinuation-emergent symptoms. Agomelatine has demonstrated a range of properties that suggest it could offer advantages over current treatments for major depressive disorder, although further comparative trials are still required, as is evidence from real-world clinical practice.

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Acknowledgements

The authors acknowledge technical support from Dr Francoise Picarel, who is an employee of Servier, and from Miss Niette Yeung at the University Health Network. Both assisted with the preparation of tables, figures and editorial support for an earlier draft of this manuscript. Dr Sidney H. Kennedy did not receive financial support for the preparation of this manuscript, but has received honoraria and research support from the Institute de Recherches Internationales Servier (IRIS). In the past 5 years, he has received honoraria or research support from Advanced Neuromodulation Systems Inc., AstraZeneca, Biovail, Boehringer Ingelheim, Brain Cells Inc., Eli Lilly, GlaxoSmithKline, Janssen-Ortho, Lundbeck, Merck Frosst, Organon, Pfizer, Servier and Wyeth. Sakina Rizvi has no conflicts of interest that are directly relevant to the content of this review.

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Kennedy, S.H., Rizvi, S.J. Agomelatine in the treatment of major depressive disorder. CNS Drugs 24, 479–499 (2010). https://doi.org/10.2165/11534420-000000000-00000

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