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A randomized , double-blind , placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder . BACKGROUND This 8-week , randomized , double-blind , placebo-controlled study , conducted August 2010-May 2012 in the United States , evaluated the safety and efficacy of vortioxetine 10 mg and 15 mg in patients with major depressive disorder ( MDD ) . The mechanism of action of vortioxetine is thought to be related to direct modulation of serotonin ( 5-HT ) receptor activity and inhibition of the serotonin transporter . METHOD Adults aged 18-75 years with MDD ( DSM-IV-TR ) and Montgomery-Asberg Depression Rating Scale ( MADRS ) total score ≥ 26 were randomized ( 1:1:1 ) to receive vortioxetine 10 mg or 15 mg or placebo once daily , with the primary efficacy end point being change from baseline at week 8 in MADRS analyzed by mixed model for repeated measures . Adverse events were recorded during the study , suicidal ideation and behavior were assessed using the Columbia-Suicide Severity Rating Scale ( C-SSRS ) , and sexual dysfunction was assessed using the Arizona Sexual Experience ( ASEX ) scale . RESULTS Of the 1,111 subjects screened , 469 subjects were randomized : 160 to placebo , 157 to vortioxetine 10 mg , and 152 to vortioxetine 15 mg . Differences from placebo in the primary efficacy end point were not statistically significant for vortioxetine 10 mg or vortioxetine 15 mg. Nausea , headache , dry mouth , constipation , diarrhea , vomiting , dizziness , and flatulence were reported in ≥ 5 % of subjects receiving vortioxetine . Discontinuation due to adverse events occurred in 7 subjects ( 4.4 % ) in the placebo group , 8 ( 5.2 % ) in the vortioxetine 10 mg group , and 12 ( 7.9 % ) in the vortioxetine 15 mg group . ASEX total scores were similar across groups . There were no clinically significant trends within or between treatment groups on the C-SSRS , laboratory values , electrocardiogram , or vital sign parameters . CONCLUSIONS In this study , vortioxetine did not differ significantly from placebo on MADRS total score after 8 weeks of treatment in MDD subjects . TRIAL REGISTRATION ClinicalTrials.gov identifier : NCT01179516 .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
vortioxetine
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
vortioxetine
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Intervention_Pharmacological
vortioxetine
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Outcome_Other
efficacy and safety
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Outcome_Other
safety and efficacy
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Outcome_Physical
serotonin ( 5-HT ) receptor activity
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Outcome_Physical
serotonin transporter .