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 .
Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder
Abstract Objective : The primary objective of this study was to evaluate the safety and tolerability of the investigational drug vortioxetine ( Lu AA21004 ) in the long-term treatment of patients with major depressive disorder . Methods : Patients entered this 52-week , open-label extension study after completing an 8-week lead-in study . Safety and tolerability were evaluated at regular intervals on the basis of spontaneously reported adverse events ( AEs ) , clinical safety laboratory tests , vital signs , ECG and physical examination . Effectiveness of treatment was assessed using the Montgomery – Åsberg Depression Rating Scale ( MADRS ) total score . Results : A total of 535 patients were treated and 61.3 % ( n = 328 ) completed the study , result ing in 393 patient years of exposure to vortioxetine . AEs reported by ≥10 % of patients were nausea , headache , and nasopharyngitis . Taken together , six patients had eight AEs related to sexual dysfunction . There were no clinical ly significant safety findings with respect to mean changes of vital signs , weight , ECG parameters , or clinical laboratory values . Patients entered the extension study with a mean MADRS total score of 13.5 ± 8.7 . The mean MADRS total score decreased ( improved ) by approximately 8 points to 5.5 ± 6.0 at Week 52 ( OC ) . By the end of the study , the proportion of responders had increased from 63 % to 94 % ( OC ) , as had the proportion in remission ( MADRS ≤10 ) , increasing from 42 % to 83 % ( OC ) . Patients in remission ( n = 226 ) at the start of this study had a relapse rate ( MADRS ≥22 ) of 9.7 % . Conclusions : As with all open-label studies , the conclusions that can be drawn are limited by the lack of a placebo control , making it difficult to assess causality of any changes in outcome measures . However , on the basis of these findings , vortioxetine ( 2.5 , 5 , 10 mg/day ) demonstrated a favourable safety and tolerability profile and maintained effectiveness over 12 months of treatment . Trial Registration : Clinical Trials.gov identifier : NCT00694304
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 .