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 trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder
Abstract Objective : Vortioxetine ( Lu AA21004 ) is an investigational antidepressant . In vitro studies indicate that vortioxetine is a 5-HT3 , 5-HT7 , and 5-HT1D receptor antagonist , 5-HT1B receptor partial agonist , 5-HT1A receptor agonist and inhibitor of the 5-HT transporter . This trial assessed the efficacy and tolerability of 2.5 and 5 mg vortioxetine for the treatment of MDD . Research design and methods : Adults ( N = 611 ) with MDD were r and omized to 8 weeks of double-blind treatment with placebo , vortioxetine ( 2.5 or 5 mg ) or active reference ( duloxetine 60 mg ) . The primary measure was change from baseline in the 24-item Hamilton Depression Scale ( HAM-D24 ) . Secondary endpoints included responder rate , Clinical Global Impression Scale-Global Improvement scale ( CGI-I ) , and remission rate . Participants were monitored for adverse events ( AEs ) , and treatment-emergent sexual dysfunction using the Arizona Sexual Experiences ( ASEX ) scale . Results : Both doses of vortioxetine were associated with declines in HAM-D24 total scores compared to placebo but were not statistically significant . At 8 weeks , changes from baseline were [ mean ( SE ) ] : −10.50 ( 0.76 ) placebo , −12.04 ( 0.74 ) 2.5 mg vortioxetine , and −11.08 ( 0.74 ) 5 mg vortioxetine . Secondary outcome measures in the vortioxetine groups , including responder rate , CGI-I , and remission rate , were also not significantly different from placebo . Duloxetine treatment was associated with declines in HAM-D24 total score [ −13.47(0.75 ) ; p = 0.005 ] as well as significant improvements in secondary outcome measures versus placebo ( p ≤ 0.05 ) . The most common AEs for vortioxetine  were nausea , dry mouth , and headache . Rates of sexual dysfunction ( ASEX ) were 51.0 % , 37.5 % , 46.9 % , and 33.3 % in the vortioxetine 2.5 mg , vortioxetine 5 mg , duloxetine , and placebo groups , respectively . Conclusions : In this study of adults with MDD treated for 8 weeks with vortioxetine 2.5 mg or 5 mg per day , reductions in depression symptoms were not statistically significant compared with placebo . Study limitations are discussed , including patient characteristics , MDD severity , drug dosing , and aspects of trial design . Both doses of vortioxetine were well tolerated . This trial has been registered at clinical trials.gov #
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 .