3009 – Randomized, double-blind, study of vortioxetine versus agomelatine in adults with MDD after inadequate response to SSRI or SNRI treatment

Abstract

Introduction Vortioxetine (Lu AA21004) is an investigational antidepressant, a multimodal 5-HT 3 , 5-HT 7 and 5-HT 1D receptor antagonist, 5-HT 1B receptor partial agonist, 5-HT 1A receptor agonist and inhibitor of the 5-HT transporter. Objectives To compare efficacy and tolerability of flexible-dose treatment with vortioxetine versus agomelatine in MDD patients who presented with an inadequate response to SSRI/SNRI monotherapy. Aims The primary efficacy endpoint was the change from baseline to Week 8 in MADRS total score analysed by MMRM using a non-inferiority test. Secondary endpoints included assessment of anxiety symptoms (HAM-A), global clinical judgment (CGI), and overall functioning (SDS). Methods Randomized, double-blind comparator study (NCT01488071). Results Eligible patients were randomized (1:1) to vortioxetine (10-20mg/day) or agomelatine (25-50mg/day) for 12 weeks of double-blind treatment. On the primary efficacy endpoint, vortioxetine (n=252) was statistically significantly superior to agomelatine (n=241) (p Conclusions The primary efficacy endpoint of this comparator study was met, with vortioxetine also showing a significant benefit compared to agomelatine in MDD patients who changed antidepressant after an inadequate response to SSRI/SNRI treatment. Statistically significant differences were seen from Week 4 onwards. This study confirms that vortioxetine is efficacious and well-tolerated.