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

  • Häggström L
  • Nielsen R
  • Dragheim M
N/ACitations
Citations of this article
9Readers
Mendeley users who have this article in their library.

Abstract

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.

Cite

CITATION STYLE

APA

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

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Save time finding and organizing research with Mendeley

Sign up for free