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, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorder.
OBJECTIVE To evaluate the efficacy , and further establish the safety profile , of oral once-daily vilazodone , a potent and selective serotonin 1A receptor partial agonist and reuptake inhibitor , in the treatment of major depressive disorder ( MDD ) . METHOD This phase 3 , r and omized , double-blind , placebo-controlled , 8-week study ( conducted March 2008-February 2009 ) enrolled 481 adults with DSM-IV-TR-defined MDD . Patients received vilazodone ( titrated to 40 mg/d ) or placebo . The primary efficacy endpoint was change in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score from baseline to end of treatment . Secondary efficacy measures included MADRS and 17-item Hamilton Depression Rating Scale ( HDRS-17 ) response and change in HDRS-17 , HDRS-21 , Hamilton Anxiety Rating Scale ( HARS ) , Clinical Global Impressions-Severity of Illness ( CGI-S ) , and Clinical Global Impressions-Improvement ( CGI-I ) scores . The Changes in Sexual Functioning Question naire ( CSFQ ) was administered at baseline and week 8 . RESULTS Vilazodone-treated patients had significantly greater improvement ( P = .009 ) according to the MADRS than placebo patients ( intent-to-treat ; least-squares mean changes : -13.3 , -10.8 ) . MADRS response rates were significantly higher with vilazodone than placebo ( 44 % vs 30 % , P = .002 ) . Remission rates for vilazodone were not significantly different based on the MADRS  ( vilazodone , 27.3 % vs placebo , 20.3 % ; P = .066 ) or HDRS-17  ( vilazodone , 24.2 % vs placebo , 17.7 % ; P = .088 ) . Vilazodone-treated patients had significantly greater improvements from baseline in HDRS-17 ( P = .026 ) , HDRS-21 ( P = .029 ) , HARS ( P = .037 ) , CGI-S ( P = .004 ) , and CGI-I ( P = .004 ) scores than placebo patients . Rates of discontinuation due to adverse events were 5.1 % ( vilazodone ) and 1.7 % ( placebo ) . The most common adverse events ( vilazodone vs placebo ) were diarrhea ( 31 % vs 11 % ) , nausea ( 26 % vs 6 % ) , and headache ( 13 % vs 10 % ) . Treatment-related effects on sexual function as measured by the CSFQ were small and similar to placebo . Effects on weight were no different from placebo . CONCLUSIONS Vilazodone 40 mg/d was well tolerated and effective in adult patients with MDD . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00683592
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 .