PURPOSE: Major depressive disorder (MDD) has detrimental effects on 
health-related quality of life (HRQoL). We describe the effect of vortioxetine 
on HRQoL in MDD patients by using patient-reported outcome instruments.
METHODS: HRQoL was evaluated in 5 short-term (6-8 weeks), randomized studies of 
vortioxetine (5-20 mg/d; n = 2155) versus placebo (n = 1316) in adults with MDD 
by using the 36-item Short-Form Health Survey (SF-36), the Quality of Life 
Enjoyment and Satisfaction Questionnaire-Short Form, the EuroQol 5-Dimension 
Questionnaire (EQ-5D), and the 12-item Health Status Questionnaire in 1 study in 
elderly patients. Only patients receiving the approved doses of vortioxetine 5, 
10, 15, or 20 mg/d were included in the analysis. A random effects meta-analysis 
was performed on the 4 adult MDD studies that used the SF-36. A within-studies 
mixed model for repeated measures analysis based on the full analysis set (FAS) 
was used unless otherwise specified. Standardized effect size (SES) was 
calculated to reflect clinical relevance, based on a Cohen's d of 0.2.
FINDINGS: Vortioxetine produced significantly better results compared with 
placebo in the SF-36 mental component summary score (5 mg: 2.6, P = 0.001, SES 
of 0.22, n = 604; 10 mg: 4.8, P < 0.001, SES of 0.42, n = 328) and 4 domain 
scores (vitality, social functioning, role emotional, and mental health). 
Vortioxetine was also significantly better in the EuroQoL-5 Dimension 
Questionnaire Health State score (10 mg: 7.5, P < 0.05, SES of 0.33, n = 86) and 
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form total score 
(15 mg: 3.3, P < 0.01, SES of 0.38, n = 127; 20 mg: 4.5, P < 0.0001, SES of 
0.52, n = 134) (FAS, last-observation-carried-forward). In the study of elderly 
patients, vortioxetine 5 mg (n = 136) improved 12-item Health Status 
Questionnaire scores significantly more than placebo (n = 148) for the domains 
of health perception (10.4, P < 0.0001, SES of 0.54), mental health (7.9, P < 
0.001, SES of 0.44), and energy (6.4, P < 0.05, SES of 0.28) (FAS, mixed model 
for repeated measures).
IMPLICATIONS: Vortioxetine yielded significant, meaningful HRQoL improvements in 
6 MDD studies of 6 to 8 weeks' duration.