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 randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD)
The efficacy , safety , and tolerability of Lu AA21004 versus placebo , using duloxetine as active reference , in patients with DSM-IV-TR diagnosed major depressive disorder ( MDD ) were evaluated in this 8-week , multi-site study . Patients ( n=766 ) had a baseline Montgomery-Åsberg Depression Rating Scale ( MADRS ) total score ≥26 and were r and omly assigned ( 1:1:1:1:1 ) to 2.5 , 5 or 10 mg Lu AA21004 , placebo , or 60 mg duloxetine . The 5 mg and 10 mg doses of Lu AA21004 were tested separately versus placebo at p≤0.025 in a pre-specified order . In the pre-defined primary efficacy analysis [ mean change from baseline in MADRS total score at Week 8 , full analysis set , ANCOVA , last observation carried forward ( LOCF ) ] , the differences to placebo ( n=145 ) of -1.7 ( Lu AA21004 5 mg , n=155 ) and -1.5 points ( Lu AA21004 10 mg , n=151 ) were not statistically significant ; nor were those for Lu AA21004 2.5 mg ( -1.4 points , n=155 ) or duloxetine ( -2.0 points , n=149 ) . Using mixed model , repeated measures ( MMRM ) analyses of the primary endpoint and most secondary endpoints were supportive of likely efficacy for Lu AA21004 5 mg and 10 mg and duloxetine . Treatment-emergent adverse events led to the withdrawal of 72 patients : 8 % ( placebo ) , 12 % ( duloxetine ) , and 6 % , 11 % and 9 % in the Lu AA21004 groups ( 2.5 mg , 5 mg and 10 mg , respectively ) . The most common adverse events were nausea , headache , dizziness , and dry mouth . No clinical ly relevant changes were seen in vital signs , weight , ECG , or laboratory results . In summary , none of the active treatment groups , including duloxetine , separated from placebo in the primary analysis in this ' failed ' study . Findings on secondary outcome measures , using MMRM instead of LOCF , were supportive of likely efficacy  for Lu AA21004 5 mg and 10 mg and duloxetine . Lu AA21004 ( 2.5 , 5 and 10 mg ) was well tolerated
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 .