The Impact of Clinical Factors, Vitamin B12 and Total Cholesterol on Severity of Anorexia Nervosa: A Multicentric Cross-Sectional Study

Severe forms of Anorexia Nervosa (AN) are characterized by medical complications, psychiatric comorbidity, and high mortality. This study investigated potential associations between clinical/biological factors and the severity of AN, measured by the Body Mass Index (BMI). Red and white blood cells, hemoglobin, platelets, iron, vitamins D and B12, folate, and total cholesterol were measured in a mixed sample of 78 inpatients and outpatients. Linear regressions and one-way analyses of variance (ANOVAs) were carried out to evaluate the relationship between BMI and clinical/biochemical variables. BMI was significantly lower in hospitalized patients (F = 4.662; p = 0.034) and in those under pharmacological treatment (F = 5.733; p = 0.019) or poly-therapy (F = 5.635; p = 0.021). Higher vitamin B12 (β = −0.556, p p = 0.027), and later age at onset (with a trend towards significance) (β = −0.376, p = 0.058) were associated with a lower BMI. Increased total cholesterol and vitamin B12, later age at onset, current pharmacological treatment, and poly-therapy might be distinctive in patients with a lower BMI. In clinical practice, these findings may contribute to the early identification of AN patients at higher risk of developing complicated or chronic forms of the disorder. Further studies on larger samples are needed to identify potential predictive factors of AN severity in the framework of precision medicine

Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trialResearch in context

Summary: Background: Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. Methods: We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). Findings: The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01–2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. Interpretation: As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. Funding: The study was funded by the Italian Medicines Agency within the “2016 Call for Independent Drug Research”