Factor V Leiden and the 10-year incidence of depression: A retrospective cohort study conducted in Germany

There is limited literature on the long-term relationship between the diagnosis of factor V Leiden (FVL) and depression. Therefore, the aim of this retrospective cohort study was to investigate the association between FVL and the 10-year incidence of depression in Germany. Patients diagnosed with FVL for the first time in one of 1,274 general practices in Germany between 2000 and 2019 were included in this study (index date). Patients without FVL were matched (1:5) to those with FVL by sex, age, index year, and the average number of consultations per year. In individuals without FVL, index date corresponded to a randomly selected visit date between 2000 and 2019. The association between the diagnosis of FVL and the 10-year incidence of depression was analyzed using Kaplan-Meier curves and Cox regression models. This study included 1,070 patients with and 5,350 patients without FVL (64.9% women; 46.0 [16.5] years). Ten years after the index date, 21.4% and 14.1% of individuals with and without FVL were diagnosed with depression, respectively (log-rank p-value<0.001). After adjusting for thromboembolic events, the Cox regression analysis further showed that FVL was associated with a significant increase in the incidence of depression (HR = 1.61, 95% CI = 1.33–1.95). In this study conducted in Germany, FVL was identified as a long-term risk factor for depression. More research is needed to confirm or refute the present findings in other settings.