INTRODUCTION<br />Vortioxetine (Lu AA21004) is an investigational antidepressant, a multimodal 5-HT3, 5-HT7 and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter. <br /><br />OBJECTIVES<br />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. <br /><br />AIMS<br />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). <br /><br />METHODS<br />Randomized, double-blind comparator study (NCT01488071). <br /><br />RESULTS<br />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<0.05) by 2.2 MADRS points. Significant differences in favour of vortioxetine were found for the MADRS, HAM-A, CGI-S, CGI-I, and SDS from Week 4 onwards (FAS, MMRM; p<0.05) and robustness was confirmed by significant differences by ANCOVA (FAS, LOCF). Fewer patients withdrew due to adverse events with vortioxetine (5.9%) than agomelatine (9.5%). Adverse events with the highest incidence were nausea, headache, dizziness and somnolence. <br /><br />CONCLUSIONS<br />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.
Häggström, L., Nielsen, R. Z., & Dragheim, M. (2013). 3009 – Randomized, double-blind, study of vortioxetine versus agomelatine in adults with MDD after inadequate response to SSRI or SNRI treatment. European Psychiatry, 28, 1. https://doi.org/10.1016/s0924-9338(13)77519-9