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 .
Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial.
INTRODUCTION Vilazodone is a potent serotonin ( 5-HT ) reuptake inhibitor and 5-HT₁A receptor partial agonist approved by the US Food and Drug Administration for the treatment of major depressive disorder ( MDD ) in adults . This study evaluated the efficacy and tolerability of vilazodone in the treatment of MDD . METHOD This 8-week , r and omized ( 1:1 ) , double-blind , placebo-controlled , parallel-group , fixed-dose study conducted from January 2012 to February 2013 compared  vilazodone 40 mg/d  with placebo in out patients with DSM-IV-TR-diagnosed MDD . The primary efficacy measure was Montgomery-Asberg Depression Rating Scale ( MADRS ) total score change from baseline to week 8 analyzed by a mixed-effects model for repeated measures on the intent-to-treat population ( placebo = 252 , vilazodone = 253 ) . Secondary efficacy outcomes were Clinical Global Impressions-Severity of Illness ( CGI-S ) Scale score change from baseline and MADRS sustained response rate ( total score ≤ 12 for at least the last 2 consecutive double-blind visits ) . RESULTS Approximately 83 % of patients completed the study . Least squares mean differences ( 95 % CI ) were statistically significant for vilazodone versus placebo  on MADRS ( -5.117 [ -6.886 to -3.347 ] , P < .00001 ) and CGI-S ( -0.622 [ -0.845 to -0.399 ] , P < .00001 ) change from baseline ; statistically significant improvements versus placebo occurred at week 2 and persisted for the study duration . The MADRS sustained response rate was 17 % for placebo and 27 % for vilazodone ( P < .01 ) . Patients taking vilazodone versus placebo had higher rates of diarrhea and nausea ; most incidences were mild in severity . Weight increase and sexual dysfunction adverse events were low in both groups . CONCLUSIONS A large and significant treatment effect on the MADRS and statistically significant improvement on the CGI-S demonstrated meaningful depressive symptom improvements . Vilazodone was generally well tolerated . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01473394
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 .