Original articleClinical efficacy of agomelatine in depression: the evidenceDen Boer, J. A.; Bosker, F. J.; Meesters, Y. Author Information Department of Psychiatry, Groningen University Medical Centre, Groningen, The Netherlands Correspondence and requests for reprints to Professor Johannes den Boer, University Hospital Groningen, Hanzeplein I, Postbus 30.001, 9700 RH Groningen, The Netherlands E-mail: [email protected] International Clinical Psychopharmacology: February 2006 - Volume 21 - Issue - p S21-S24 doi: 10.1097/01.yic.0000195661.37267.86 Buy Metrics Abstract Despite the advances of recent decades, there is still an urgent need for antidepressants with improved efficacy, safety and tolerability. Agomelatine is a new antidepressant with an innovative pharmacological profile. It is the first melatonergic antidepressant, and is a potent agonist of melatonin receptors (MT1 and MT2) with 5-HT2C antagonist properties. The efficacy of 25 mg/day agomelatine in treating major depressive disorder (MDD) has been demonstrated in a number of placebo-controlled studies. Evidence of improvement in depressive symptoms was observed in a dose-ranging study in which 25 mg/day agomelatine was significantly better than placebo, whatever the rating scale used (Hamilton Rating Scale for Depression, Clinical Global Impression, and Montgomery–Åsberg Depression Rating Scale). These results have been confirmed in two similarly designed placebo-controlled studies. Agomelatine also produces a significant improvement in anxiety compared to placebo, according to Hamilton Rating Scale for Anxiety scores. The efficacy of agomelatine has been studied in subpopulations with more severe depression, demonstrating its efficacy in these difficult-to-treat patients. In view of the available data on agomelatine, this antidepressant can be regarded as an innovative treatment for MDD patients, offering a new approach in the management of depressed patients. © 2006 Lippincott Williams & Wilkins, Inc.