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 .
Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE The efficacy and tolerability of vilazodone , a combined selective serotonin reuptake inhibitor and partial 5-hydroxytryptamine-1A ( 5-HT(1A ) ) receptor agonist , were evaluated in adult patients with major depressive disorder ( MDD ) . METHOD This was a r and omized , double-blind , placebo-controlled trial conducted from February 2006 to May 2007 . Patients aged 18 through 65 years with MDD ( DSM-IV criteria ) and a baseline 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) score of > or= 22 were r and omly assigned to vilazodone or placebo for 8 weeks .  Vilazodone was titrated from 10 mg to 40 mg once a day over 2 weeks .  Efficacy was assessed by mean change from baseline to week 8 on the Montgomery-Asberg Depression Rating Scale ( MADRS ) , HAM-D-17 , and Hamilton Rating Scale for Anxiety . Response rates were determined at week 8 for the MADRS , HAM-D-17 , and Clinical Global Impressions-Severity of Illness ( CGI-S ) and -Improvement ( CGI-I ) scales . Data were analyzed using a modified last-observation-carried-forward method in the intention-to-treat ( ITT ) sample . The Arizona Sexual Experience Scale ( ASEX ) was also measured at baseline and week 8 . RESULTS Of 410 r and omly assigned patients , 198 receiving vilazodone and 199 receiving placebo were included in the ITT population . The mean changes in MADRS and HAM-D-17 total scores from baseline to week 8 were significantly ( p = .001 and p = .022 , respectively ) greater with vilazodone than with placebo . Significant ( p < .05 ) improvements in MADRS and HAM-D-17 scores were noted at week 1 , the earliest time point measured . Response rates were significantly higher with vilazodone than with placebo on the MADRS ( p = .007 ) , HAM-D-17 ( p = .011 ) , and CGI-I ( p = .001 ) . Treatment-emergent adverse events with vilazodone included diarrhea , nausea , and somnolence ; most adverse events were of mild or moderate intensity . There were no clinical ly significant differences for either gender in ASEX scores at end of treatment . CONCLUSIONS Vilazodone is effective for the treatment of MDD in adults , with symptom relief starting at 1 week , and is well tolerated at a dose of 40 mg/day . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00285376
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 .