A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults

We primarily aimed to evaluate the efficacy of vortioxetine 10 and 20 mg/d vs. placebo on cognitive function in adults with recurrent Major depressive disorder during a depressive episode of moderate severity or greater

Roger S. McIntyre


Scholarcy highlights

  • Major depressive disorder is a common mental disorder often associated with deficits in cognitive function
  • The present study aimed to extend the investigation to the adult MDD population including a broader assessment of objective and subjective measures of cognition in addition to depressive symptoms, safety and tolerability as secondary outcomes
  • In addition to demonstrating efficacy on a composite cognition score based on two tests covering several domains of relevance for patients with MDD, improvement with vortioxetine treatment was noted on secondary objective and subjective measures of cognitive function
  • Improvement vs. placebo was seen on all included measures of executive function, attention, and processing speed, as well as with learning and memory
  • The clinical relevance of the significant effect of vortioxetine on objective neuropsychological test scores was supported by the magnitude of the standardized effect sizes, which ranged from 0.23 to 0.52 where p < 0.05 and were above the clinically meaningful threshold of 0.2
  • In the pre-defined primary efficacy analysis, both doses of vortioxetine were significantly superior vs. placebo in mean change from baseline to week 8 in the composite z-score), with a mean treatment difference to placebo of 0.36 and 0.33
  • The present study extended the evidence of the positive effect of vortioxetine on cognitive function previously demonstrated in patients aged 565 yr with MDD, in which vortioxetine separated from placebo in both the Digit Symbol Substitution Test and the Rey Auditory Verbal Learning Test with standardized effect sizes a little lower than those found in the present study
  • Notwithstanding, this appears to be the first large randomized study in adults to document a beneficial effect on a composite measure of cognitive function in Major depressive disorder, wherein the pre-defined primary clinical outcome was cognitive performance as well as consistent improvement across a range of neuropsychological tests

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