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Inpharma 1356 - 21 Sep 2002 Agomelatine shows efficacy in the treatment of major depression, according to a multinational group of researchers. They randomised 711 adult patients with major depressive disorder or bipolar II disorder to treatment with agomelatine 1 mg/day (n = 141), 5 mg/day (147), 25 mg/day (137), paroxetine 20 mg/day (147), or placebo, for 8 weeks. Treatment with either agomelatine 25 mg/day or paroxetine resulted in significantly lower mean HAM-D * final scores, compared with placebo (12.77 and 13.09 vs 15.34, respectively). Furthermore, there were significantly more remitters in the agomelatine 25 mg/day and paroxetine groups, compared with the placebo group (30.4% and 25.7% vs 15.4% of patients). ** A significantly higher proportion of patients treated with agomelatine 1 or 25 mg/day were classed as responders, compared with patients in the placebo group (62.5% and 61.5% vs 46.3%). However, this difference was not observed for paroxetine-treated patients. Agomelatine appeared to be better tolerated than paroxetine, with an adverse event profile similar to that of placebo. * Hamilton Rating Scale for Depression ** Remitters were defined as patients with a HAM-D score of < 7. † Responders were defined as patients with a 50% improvement from baseline in their HAM-D score. oo H, et al. Determination of the dose of agomelatine, a melatoninergic agonist and selective 5-HT(2C) antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study. International Clinical Psychopharmacology 17: 239-247, Sep 2002 800917195 » Editorial comment: Agomelatine is under development by Servier, and is currently undergoing phase III trials for the treatment of depression. 1 Inpharma 21 Sep 2002 No. 1356 1173-8324/10/1356-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Agomelatine: efficacy in treatment of major depression

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Inpharma 1356 - 21 Sep 2002

■ Agomelatine shows efficacy in the treatment ofmajor depression, according to a multinational groupof researchers. They randomised 711 adult patientswith major depressive disorder or bipolar II disorder totreatment with agomelatine 1 mg/day (n = 141), 5mg/day (147), 25 mg/day (137), paroxetine 20 mg/day(147), or placebo, for 8 weeks. Treatment with eitheragomelatine 25 mg/day or paroxetine resulted insignificantly lower mean HAM-D* final scores,compared with placebo (12.77 and 13.09 vs 15.34,respectively). Furthermore, there were significantlymore remitters in the agomelatine 25 mg/day andparoxetine groups, compared with the placebo group(30.4% and 25.7% vs 15.4% of patients).** Asignificantly higher proportion of patients treated withagomelatine 1 or 25 mg/day were classed asresponders, compared with patients in the placebogroup (62.5% and 61.5% vs 46.3%).† However, thisdifference was not observed for paroxetine-treatedpatients. Agomelatine appeared to be better toleratedthan paroxetine, with an adverse event profile similarto that of placebo.* Hamilton Rating Scale for Depression** Remitters were defined as patients with a HAM-D score of < 7.† Responders were defined as patients with a ≥ 50% improvementfrom baseline in their HAM-D score.

Loo H, et al. Determination of the dose of agomelatine, a melatoninergicagonist and selective 5-HT(2C) antagonist, in the treatment of majordepressive disorder: a placebo-controlled dose range study. InternationalClinical Psychopharmacology 17: 239-247, Sep 2002 800917195

» Editorial comment: Agomelatine is under developmentby Servier, and is currently undergoing phase III trials for thetreatment of depression.

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Inpharma 21 Sep 2002 No. 13561173-8324/10/1356-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved