Background: Vortioxetine is a multimodal antidepressant that has been developed for the
treatment of major depressive and anxiety disorders. The aim of this review is to quantitatively synthesize
all data of the efficacy, safety and tolerability of Vortioxetine in treating anxiety disorder.
Method: Terms of “Vortioxetine” OR “LuAA21004” AND “anxiety” OR “fear” OR “panic” OR
“phobia” were searched. A total of two phase II and five phase III clinical trials were found.
Results: Vortioxetine was overall superior to placebo in terms of the mean change from baseline in
HAM-A total score at week 8 with the pool effect size of -2.95, 95% CIs, -4.37 to -1.53, p<0.01. The
patients who received 5 mg of Vortioxetine had higher response rate when compared to placebo
(pooled odds ratio=1.4, 95% CI = 1.08 to 1.82, p=0.01). However, the pooled odds ratio of the HAMA
remission rate was not statistically significant for both Vortioxetine and placebo (pooled odds ratio=
1.06, 95% CI = 0.86 to 1.30, p=0.62). Although the discontinuation due to adverse effects was
higher in Vortioxetine than placebo group (pooled OR= 1.55, 95% CI = 1.04 to 2.31, P= 0.037), the
lack of efficacy (pooled OR= 0.39, 95% CI = 0.27 to 0.57, P<0.01) was higher in placebo than Vortioxetine
group. Most of the adverse effects were mild and moderate. Overall, Vortioxetine displayed a
good safety and tolerability profile.
Conclusion: This review supports the use of Vortioxetine for anxiety disorder. However, further longterm
placebo-control observational study or a post market survey would help in strengthening the evidence
for this treatment modality.