Systematic review of gender bias in vortioxetine clinical trials

Abstract

This paper evaluates gender bias in the published clinical trials of Vortioxetine. We conducted a systematic review of controlled clinical trials of Vortioxetine for the treatment of depression. The literature search was performed using MEDLINE and following the corresponding international recommendations. We identified 42 articles, of which 23 were included. The proportion of women ranged from 47%-75% and the percentage of women included in the 10,404 total patients sample was 65%. The separate analysis of the main variable between the subpopulations of men and women was only carried out in 3/23 publications included. In contrast, 6/23 trials analyzed secondary variables separated by sex. No trials discussed the results separately by sex. The proportion of women included was slightly higher than that in clinical trials of other antidepressants. However, the analysis of the main result or secondary variables by sex, as well as discussing the results separately by sex, are scarce. This gives rise to gender bias in these works.

Keywords: Controlled clinical trials; Gender bias; Vortioxetine.