EXPERT OPINION Results of placebo-controlled trials suggest efficacy and an overall safety profile comparable to existing first-line antidepressants .
The most common side effects are nausea , vomiting and constipation .
Results of several studies indicate that vortioxetine may have therapeutic effects on cognition ( e.g. , memory and executive functioning ) that exceed that of st and ard antidepressants .
The authors suggest that vortioxetine is currently a good second-line antidepressant option and shows promise , pending additional long-term data , to become a first-line antidepressant option
INTRODUCTION Vortioxetine is a structurally novel medication that has recently been approved for treatment of major depressive disorder ( MDD ) .
This medication is a serotonin reuptake inhibitor that also has a number of other potentially relevant effects on serotoninergic receptors , which may differentiate the drug 's effects from those of current first-line antidepressants , such as selective serotonin reuptake inhibitors ( SSRIs ) and serotonin norepinephrine reuptake inhibitors ( SNRIs ) .
AREAS COVERED This article will review the basic clinical pharmacology of vortioxetine , summarize the major clinical trials that were performed prior to approval by the US Food and Drug Administration ( FDA ) , discuss relevant post-marketing studies of this drug , and offer expert commentary on the significance of this new agent in clinical practice .
A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults
The efficacy of vortioxetine 10 and 20 mg/d vs. placebo on cognitive function and depression in adults with recurrent moderate-to-severe major depressive disorder ( MDD ) was evaluated . Patients ( 18–65 yr , N = 602 ) were r and omized ( 1:1:1 ) to vortioxetine  10 or 20 mg/d  or placebo for 8 wk in a double-blind multi-national study . Cognitive function was assessed with objective neuropsychological tests of executive function , processing speed , attention and learning and memory , and a subjective cognitive measure . The primary outcome measure was change from baseline to week 8 in a composite z-score comprising the Digit Symbol Substitution Test ( DSST ) and Rey Auditory Verbal Learning Test ( RAVLT ) scores . Depressive symptoms were assessed using the Montgomery-Åsberg Depression Rating Scale ( MADRS ) . In the pre-defined primary efficacy analysis , both doses of vortioxetine were significantly better than placebo , with mean treatment differences vs. placebo of 0.36 ( vortioxetine 10 mg , p < 0.0001 ) and 0.33 ( vortioxetine 20 mg , p < 0.0001 ) on the composite cognition score . Significant improvement vs. placebo was observed for vortioxetine on most of the secondary objectives and subjective patient-reported cognitive measures . The differences to placebo in the MADRS total score at week 8 were −4.7 ( 10 mg : p < 0.0001 ) and −6.7 ( 20 mg : p < 0.0001 ) . Path and subgroup analyses indicate that the beneficial effect of vortioxetine on cognition is largely a direct treatment effect . No safety concern emerged with vortioxetine . Vortioxetine significantly improved objective and subjective measures of cognitive function in adults with recurrent MDD and these effects were largely independent of its effect on improving depressive symptoms
EXPERT OPINION Results of placebo-controlled trials suggest efficacy and an overall safety profile comparable to existing first-line antidepressants .
The most common side effects are nausea , vomiting and constipation .
Results of several studies indicate that vortioxetine may have therapeutic effects on cognition ( e.g. , memory and executive functioning ) that exceed that of st and ard antidepressants .
The authors suggest that vortioxetine is currently a good second-line antidepressant option and shows promise , pending additional long-term data , to become a first-line antidepressant option
INTRODUCTION Vortioxetine is a structurally novel medication that has recently been approved for treatment of major depressive disorder ( MDD ) .
This medication is a serotonin reuptake inhibitor that also has a number of other potentially relevant effects on serotoninergic receptors , which may differentiate the drug 's effects from those of current first-line antidepressants , such as selective serotonin reuptake inhibitors ( SSRIs ) and serotonin norepinephrine reuptake inhibitors ( SNRIs ) .
AREAS COVERED This article will review the basic clinical pharmacology of vortioxetine , summarize the major clinical trials that were performed prior to approval by the US Food and Drug Administration ( FDA ) , discuss relevant post-marketing studies of this drug , and offer expert commentary on the significance of this new agent in clinical practice .