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 trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder.
OBJECTIVE Lu AA21004 is an investigational multimodal antidepressant . This r and omized controlled trial evaluated the efficacy and tolerability of multiple doses of Lu AA21004 versus placebo in adults with major depressive disorder ( MDD ) . METHOD Adults diagnosed with MDD ( based on DSM-IV-TR criteria ) with a Montgomery-Asberg Depression Rating Scale ( MADRS ) score ≥ 26 were r and omly assigned ( 1:1:1:1 ) to receive Lu AA21004  1 mg , 5 mg , or 10 mg or placebo for 8 weeks ( between August 2008 and August 2009 ) . The primary endpoint was reduction in 24-Item Hamilton Depression Rating Scale ( HDRS-24 ) total score after 8 weeks of treatment compared with placebo for Lu AA21004 10 mg . Additional outcomes included response and remission rates , Sheehan Disability Scale ( SDS ) , Clinical Global Impressions-Global Improvement scale ( CGI-I ) , MADRS total score , and HDRS-24 total score  in subjects with baseline Hamilton Anxiety Rating Scale ( HARS ) score ≥ 20 . Adverse events were assessed throughout the study . RESULTS A total of 560 subjects ( mean age = 46.4 years ) were r and omized . There was a statistically significant reduction from baseline in HDRS-24 total score at week 8 for Lu AA21004 10 mg vs placebo ( P < .001 ) . There were improvements ( nominal P values < .05 with no adjustment for multiplicity ) in HDRS-24 total score , response and remission rates , CGI-I score , MADRS total score , and HDRS-24 total score in subjects with baseline HARS score ≥ 20 at week 8 for all Lu AA21004 treatment groups vs placebo . No significant differences were seen in SDS scores between any dose of Lu AA21004 and placebo . The most common adverse events were nausea , headache , and dizziness . CONCLUSIONS After 8 weeks of treatment with Lu AA21004 10 mg , there was a significant reduction in HDRS-24 total score compared with placebo in adults with MDD . Lu AA21004 was well tolerated in this study . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00735709
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 .