Vortioxetine has a beneficial pharmacological profile for reducing anxiety and 
depression. Recently, a number of randomized, double-blind, placebo-controlled 
clinical trials (RCTs) of vortioxetine have been conducted in patients with 
generalized anxiety disorder (GAD); however, the results from GAD RCTs are 
inconsistent. With an extensive search of databases and clinical trial 
registries, four published short-term RCTs were identified and included in the 
present meta-analysis. The mean change in total scores on the Hamilton Anxiety 
Rating Scale (HAMA) from baseline was the primary endpoint. The secondary 
endpoints included the response and remission rates, as defined by a ≥50% 
reduction in HAMA total scores and a ≤7 change in the HAMA total score at the 
end of treatment. In addition, the mean change in the HAMA total score from 
baseline in the subgroup with a HAMA total score ≥25 at baseline was included. 
Vortioxetine was significantly more effective than was placebo, with a 
standardized mean difference (SMD) of -0.118 (95% CIs, -0.203 to -0.033, 
P = 0.007). In particular, those with severe GAD (HAMA total score ≥25 at 
baseline) had a significantly greater benefit from vortioxetine than those 
without (SMD = -0.338, 95% CIs = -0.552 to -0.124, p = 0.002). The odds ratios 
(ORs) for vortioxetine for response and remission were 1.221 (95% CIs, 1.027 to 
1.452, P = 0.024) and 1.052 (95% CIs, 0.853 to 1.296, P = 0.637), respectively. 
Discontinuation due to adverse events (AEs) (OR = 1.560, 1.006 to 2.419, 
p = 0.047) was marginally higher in vortioxetine than placebo treatment, whereas 
discontinuation due to any reason (OR = 0.971, 0.794 to 1.187, p = 0.771) and 
inefficacy (OR = 0.687, 0.380 to 1.243, p = 0.215) were not significantly 
different among treatment groups. Although our results suggest that vortioxetine 
may have a potential as an another treatment option for GAD (especially for 
severe GAD), they should be interpreted and translated into clinical practice 
with caution, as the meta-analysis was based on a limited number of RCTs.