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, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD
Rationale Vortioxetine has reduced depressive symptoms in adults with major depressive disorder ( MDD ) in multiple clinical trials . Objectives The aim of this study is to evaluate the efficacy , safety , and tolerability of vortioxetine 15 and 20 mg vs placebo in adults with MDD . Methods Patients were r and omized 1:1:1:1 to vortioxetine 15 mg , vortioxetine 20 mg , duloxetine 60 mg ( active reference ) , or placebo . The primary efficacy endpoint was mean change in Montgomery – Åsberg Depression Rating Scale ( MADRS ) total score at week 8 ( MMRM ) . Safety/tolerability assessment s included physical examinations , vital signs , laboratory evaluations , electrocardiograms , adverse events ( AEs ) , Columbia – Suicide Severity Rating Scale , Arizona Sexual Experiences Scale , and Discontinuation – Emergent Signs and Symptoms checklist . Results Six hundred and fourteen patients were r and omized . Mean changes in MADRS scores were −12.83 ( ±0.834 ) , −14.30 ( ±0.890 ) , −15.57 ( ±0.880 ) , and −16.90 ( ±0.884 ) for placebo , vortioxetine 15 mg ( P = .224 ) , vortioxetine 20 mg ( P = .023 ) , and duloxetine 60 mg ( P < .001 ) ( P vs placebo ) , respectively . AEs reported by ≥5 % of vortioxetine patients included nausea , headache , diarrhea , dizziness , dry mouth , constipation , vomiting , insomnia , fatigue , and upper respiratory infection . Treatment-emergent sexual dysfunction , suicidal ideation or behavior , and discontinuation symptoms were not significantly different between vortioxetine and placebo . Conclusions Vortioxetine 20 mg significantly reduced MADRS total scores after 8 weeks of treatment . Both vortioxetine doses were well tolerated . Clinical trial registration Clinical Trials.gov identifier NCT01153009 ; www . clinical
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 .