Vortioxetine is approved for the treatment of adults with major depressive 
disorder. This open-label extension (OLE) study evaluated the safety and 
tolerability of vortioxetine in the long-term treatment of major depressive 
disorder patients, as well as evaluated its effectiveness using measures of 
depression, anxiety, and overall functioning. This was a 52-week, flexible-dose, 
OLE study in patients who completed one of three randomized, double-blind, 
placebo-controlled, 8-week vortioxetine trials. All patients were switched to 
10 mg/day vortioxetine for week 1, then adjusted between 15 and 20 mg for the 
remainder of the study, but not downtitrated below 15 mg. Safety and 
tolerability were assessed on the basis of treatment-emergent adverse events 
(TEAEs), vital signs, laboratory values, physical examination, and the 
Columbia-Suicide Severity Rating Scale. Efficacy measures included the 
Montgomery-Åsberg Depression Rating Scale, the Hamilton Anxiety Scale, the 
Clinical Global Impression Scale-Severity of Illness, and the Sheehan Disability 
Scale. Of the 1075 patients enrolled, 1073 received at least one dose of 
vortioxetine and 538 (50.0%) completed the study. A total of 537 patients 
withdrew early, with 115 (10.7% of the original study population) withdrawing 
because of TEAEs. Long-term treatment with vortioxetine was well tolerated; the 
most common TEAEs (≥10%) were nausea and headache. Laboratory values, vital 
signs, and physical examinations revealed no trends of clinical concern. The 
mean Montgomery-Åsberg Depression Rating Scale total score was 19.9 at the start 
of the extension study and 9.0 after 52 weeks of treatment (observed cases). 
Similar improvements were observed with the Hamilton Anxiety Scale (Δ-4.2), the 
Clinical Global Impression Scale-Severity of Illness (Δ-1.2), and the Sheehan 
Disability Scale (Δ-4.7) total scores after 52 weeks of treatment (observed 
case). In this 52-week, flexible-dose OLE study, 15 and 20 mg vortioxetine were 
safe and well tolerated. After entry into this study, patients continued to show 
improvement in depression and anxiety symptoms, as well as overall functioning, 
throughout the treatment period.