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 clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder
The efficacy and tolerability of Lu AA21004 in the prevention of relapse of major depressive disorder ( MDD ) in patients in remission after acute treatment was evaluated . Patients ( n=639 ) aged 18–75 years with a primary diagnosis of MDD with a current major depressive episode ( MDE ) ≥4 weeks ’ duration , at least one prior MDE and a MADRS total score ≥26 received 12-week , open-label Lu AA21004 at 5 or 10mg/day . Patients in remission ( MADRS ≤10 ) at both weeks 10 and 12 were assigned to double-blind treatment with either placebo or Lu AA21004 ( fixed dose from Week 8) . Patients ( n=396 ) were treated , after r and om assignment to placebo ( n=192 ) or Lu AA21004 ( n=204 ) . The primary analysis of time to relapse ( full- analysis set , Cox proportional hazard model ) showed a statistically significant difference in favour of Lu AA21004 versus placebo with a hazard ratio of 2.01 ( 95 % confidence interval : 1.26–3.21 ; p=0.0035 ) . The proportion of patients who relapsed was 13 % in the Lu AA21004 group ( n=27 ) and 26 % in the placebo group ( n=50 ) . The withdrawal rates due to adverse events were 8 % ( open-label ) , and 3 % ( placebo ) and 8 % ( Lu AA21004 ) ( double-blind ) . Thus , Lu AA21004 was effective in preventing relapse of MDD and was well tolerated as maintenance treatment
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 .