Comparative assessment of safety and efficacy of Vortioxetine with Escitalopram in patients with MDD (Major Depressive Disorder): a randomized, comparative, parallel group, open-label study
Keywords:
vortioxetine, escitalopram, depression, cognitionAbstract
Background & Objectives: SSRIs and SNRIs are the preferred treatment options for patients of Major Depressive Disorder (MDD). But nonadherence and premature discontinuation due to side effects is a problem with these agents. These agents also do not adequately address cognitive dysfunction associated with MDD. Vortioxetine is a novel agent, which is known to have good efficacy and pro-cognitive property as well as good tolerability. Since there are very few studies, we aimed to compare efficacy and safety of vortioxetine with escitalopram in patients of MDD.
Methods: 60 patients were randomized in 1:1 ratio to receive either vortioxetine 10mg or escitalopram 10mg for 8 weeks. Primary efficacy measure was mean change in MADRS score from baseline to 8 weeks. Secondary efficacy measures were mean change in HDRS and CGI scores. Cognitive improvement was measured using mean change in DSST and PDQ-5 scores. Safety was compared using mean change in the values of baseline laboratory parameters and weight at the end of 8 weeks’ treatment and adverse events were also recorded in each group.
Results: Mean change in MADRS was significantly better in vortioxetine compared to escitalopram(p<0.05). Mean change in HDRS was numerically higher in vortioxetine but statistically not significant. Mean change in CGI-S was significantly better in vortioxetine group, but CGI-I score was similar in both groups. In terms of cognitive improvement vortioxetine was significantly better on both DSST and PDQ-5 scales.
Conclusion: Vortioxetine may be a better option in MDD patients with cognitive dysfunction.
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