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Psych Congress  

A randomised, double-blind, placebo-controlled, duloxetine-referenced study of the efficacy and safety of vortioxetine in acute treatment of MDD

Jean-Philippe Boulenger. MD. Henrik Loft, M.Sc. Christina Kurre Olsen, PhD.
Takeda Pharmaceutical Company, Ltd and H. Lundbeck A/S

Objective: This multi-national study assessed the efficacy, tolerability, and safety of vortioxetine versus placebo in adult patients with major depressive disorder (MDD).
Methods: This 8-week study included 608 patients with a primary diagnosis of recurrent MDD with a current major depressive episode >3 months in duration, a MADRS total score ≥26 and a CGI-S score ≥4. Patients who had previously failed to respond to duloxetine were excluded. Patients were randomly assigned (1:1:1:1) to vortioxetine 15mg/day, vortioxetine 20mg/day, duloxetine 60mg/day (active reference), or placebo for 8 weeks. The primary efficacy endpoint was change from baseline in MADRS total score at Week 8 (MMRM). Key secondary endpoints were: MADRS responders; CGI-I score; MADRS total score in patients with baseline HAM-A>20; remission (MADRS<10); and SDS total score at Week 8. 
Results: Both doses of vortioxetine were statistically significantly superior to placebo in mean change from baseline in MADRS total score at Week 8, with a mean treatment difference to placebo (n=158) of -5.6 (vortioxetine 15mg, p<0.0001, n=149) and -7.1 points (vortioxetine 20mg, p<0.0001, n=151). Duloxetine (n=146) separated from placebo, confirming assay sensitivity. In all predefined key secondary analyses, both doses of vortioxetine were statistically significantly superior to placebo. Overall, treatment with vortioxetine was well tolerated: common adverse events (>5%) were nausea, headache, diarrhoea, dry mouth and dizziness. No clinically relevant changes were seen in clinical safety laboratory values, weight, ECG or vital signs parameters.
Conclusions: Vortioxetine (15 and 20mg/day) was efficacious and well tolerated in the treatment of adults with MDD.

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