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 double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder
The efficacy , safety , and tolerability of Lu AA21004 vs. placebo using venlafaxine XR as active reference in patients with DSM-IV-TR major depressive disorder ( MDD ) were evaluated . Lu AA21004 is a novel antidepressant that is a 5-HT3 and 5-HT7 receptor antagonist , 5-HT1A receptor agonist , 5-HT1B receptor partial agonist and inhibitor of the 5-HT transporter in recombinant cell lines . In this 6-wk , multi-site study , 429 patients were r and omly assigned ( 1:1:1:1 ) to 5 or 10 mg Lu AA21004 , placebo or 225 mg venlafaxine XR .  All patients had a baseline Montgomery – Åsberg Depression Rating Scale ( MADRS ) total score ⩾30 . The primary efficacy analysis was based on the MADRS total score adjusting for multiplicity using a hierarchical testing procedure starting with the highest dose vs. placebo . Lu AA21004 was statistically significantly superior to placebo ( n=105 ) in mean change from baseline in MADRS total score at week 6 ( p<0.0001 , last observation carried forward ) , with a mean treatment difference vs. placebo of 5.9 ( 5 mg , n=108 ) , and 5.7 ( 10 mg , n=100 ) points . Venlafaxine XR ( n=112 ) was also significantly superior to placebo at week 6 ( p<0.0001 ) . In total , 30 patients withdrew due to adverse events ( AEs ) – placebo : four ( 4 % ) ; 5 mg Lu AA21004 : three ( 3 % ) ; 10 mg Lu AA21004 : seven ( 7 % ) ; and venlafaxine : 16 ( 14 % ) . The most common AEs were nausea , headache , hyperhidrosis , and dry mouth . No clinical ly relevant changes over time were seen in the clinical laboratory results , vital signs , weight , or ECG parameters . In this study , treatment with 5 mg and 10 mg Lu AA21004 for 6 wk was efficacious and well tolerated in patients with MDD
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 .