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 the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder.
BACKGROUND This 8-week , r and omized , double-blind , placebo-controlled study , conducted August 2010-May 2012 in the United States , evaluated the safety and efficacy of vortioxetine 10 mg and 15 mg in patients with major depressive disorder ( MDD ) . The mechanism of action of vortioxetine is thought to be related to direct modulation of serotonin ( 5-HT ) receptor activity and inhibition of the serotonin transporter . METHOD Adults aged 18 - 75 years with MDD ( DSM-IV-TR ) and Montgomery-Asberg Depression Rating Scale ( MADRS ) total score ≥ 26 were r and omized ( 1:1:1 ) to  receive vortioxetine 10 mg or 15 mg or placebo once daily , with the primary efficacy end point being change from baseline at week 8 in MADRS analyzed by mixed model for repeated measures . Adverse events were recorded during the study , suicidal ideation and behavior were assessed using the Columbia-Suicide Severity Rating Scale ( C-SSRS ) , and sexual dysfunction was assessed using the Arizona Sexual Experience ( ASEX ) scale . RESULTS Of the 1,111 subjects screened , 469 subjects were r and omized : 160 to placebo , 157 to vortioxetine 10 mg , and 152 to vortioxetine 15 mg . Differences from placebo in the primary efficacy end point were not statistically significant for vortioxetine 10 mg or vortioxetine 15 mg . Nausea , headache , dry mouth , constipation , diarrhea , vomiting , dizziness , and flatulence were reported in ≥ 5 % of subjects receiving vortioxetine . Discontinuation due to adverse events occurred in 7 subjects ( 4.4 % ) in the placebo group , 8 ( 5.2 % ) in the vortioxetine 10 mg group , and 12 ( 7.9 % ) in the vortioxetine 15 mg group . ASEX total scores were similar across groups . There were no clinical ly significant trends within or between treatment groups on the C-SSRS , laboratory values , electrocardiogram , or vital sign parameters . CONCLUSIONS In this study , vortioxetine did not differ significantly from placebo on MADRS total score after 8 weeks of treatment in MDD subjects . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01179516
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 .