Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day

This study evaluated the efficacy, safety and tolerability of two fixed doses of vortioxetine compared with placebo after 8 weeks of treatment in patients with major depressive disorder

Jean-Philippe Boulenger; Henrik Loft; Christina Kurre Olsen

2013

Scholarcy highlights

  • The bis-arylsulfanyl amine compound vortioxetine is a novel multimodal antidepressant
  • All the patients had experienced a previous major depressive episode, and the current episode had typically started about 6–7 months before enrolment
  • Patients had a mean number of two previous MDEs and a median duration of 22 weeks for the current MDE, and over half of the patients had one previous MDE, 24.5% had two and 24.3% had at least three previous MDEs
  • There was a substantial level of anxiety symptoms, indicated by a mean baseline Hamilton Anxiety Rating Scale total score of 20.8
  • This study evaluated the efficacy, safety and tolerability of two fixed doses of vortioxetine compared with placebo after 8 weeks of treatment in patients with major depressive disorder
  • As well as duloxetine 60 mg, demonstrated a statistically significant effect on the primary and all key secondary efficacy criteria in prespecified testing sequence. Both doses of vortioxetine were well tolerated, with nausea and headaches being the adverse events with the highest incidence

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