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 .
Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study.
OBJECTIVE To investigate the efficacy , safety , and clinical benefit of a once-daily formulation of trazodone ( Trazodone Contramid((c ) ) OAD ) in the treatment of major depressive disorder . DESIGN / PARTICIPANTS In this double-blind study , 412 patients with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria ) were r and omized 1:1 to receive either Trazodone Contramid OAD ( 150 to 375 mg ) or placebo . Treatment was titrated over two weeks to each individual optimal dose . Patients then continued six weeks of treatment ; further dose adjustments were allowed based on efficacy and tolerability . MEASUREMENTS The primary end point was change in the 17-item Hamilton Depression Rating Scale total score from baseline to last study visit . Secondary end points included Hamilton Depression Rating Scale responders/remitters , change in Montgomery-Asberg Depression Rating Scale , Clinician and Patient Global Improvement Scales , and quality of sleep . RESULTS From the end of titration to the end of the six-week treatment period , the mean maximum daily dose of the intent-to-treat population was 310 mg for the active group and 355 mg for the placebo group . There was a statistically significant difference between trazodone and placebo on the mean HAMD-17 score ( -11.4 vs. -9.3 , P=0.012 ) . A significant difference was present as early as Week 1 and was maintained at all subsequent study visits . Many secondary end points supported these findings , including improvements in quality of sleep . The most frequent adverse events were the same for both the treatment and placebo groups : headache and somnolence . There were no serious adverse events that were considered related to treatment . There were no clinical ly significant electrocardiogram or laboratory abnormalities . CONCLUSIONS The trazodone Contramid formulation was more effective than placebo in major depressive disorder and was well tolerated
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 .