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Kennedy S.H. Fvedisova A. Giménez-Montesinos N. Belaïdi C., Christian De, Bodinat, Mosolov S.N.
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European Neuropsychopharmacology
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A randomised placebo-controlled “dose relation study” was conducted in 549 patients who met the criteria for major depressive disorder, to evaluate the efficacy and safety of three doses regimens of agomelatine during 6 weeks: low fixed dosage (10 mg/day, n=133), fixed dosage (25 mg/day, n=138) and a flexible dosage with up-titration in case of insufficient improvement at week 2 (25-50 mg/day, n=137). At last post-baseline assessment, there were significant and incremental placebo-agomelatine differences on mean HAM-D17 total scores in favour of each agomelatine dose regimen (2.46±0.76 points, p=0.001 at 10 mg; 4.71+0.75 points, p<0.0001 at 25 mg and 4.92±0.76 points, p<0.0001 at 25-50 mg) with statistically significant differences between 25 mg and 25-50 mg dose regimens compared to the 10 mg dose.
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