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 trial.

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".

Association of traumatic events with levels of psychological distress and depressive symptoms in male asylum seekers and refugees resettled in Italy.

BACKGROUND: In recent years there has been a progressive rise in the number of asylum seekers and refugees displaced from their country of origin, with significant social, economic, public health and mental health implications. The aim of this study is to (1) describe the level of psychological distress and frequency of psychiatric disorders in a sample of male asylum seekers and refugees across different ethnic groups resettled in Italy; (2) establish whether the number of traumatic events experienced before, during and after the migration process is associated with level of psychological distress and depressive symptoms. METHODS: In two large Italian catchment areas, over a period of 1 year a consecutive series of male asylum seekers and refugees, aged 18 or above and included in the Italian protection system, were screened for psychological distress and psychiatric disorders using validated questionnaires. RESULTS: During the study period, 252 male asylum seekers or refugees were recruited. More than one-third of the participants (34.5%) showed clinically relevant psychological distress, and one-fourth (22.2%), met the criteria for a psychiatric diagnosis, mainly Post Traumatic Stress Disorder and depressive disorders. The number of traumatic events turned out to be a risk factor for both clinically relevant psychological distress and depressive disorders. Receiving good social support emerged as a protective factor, while migrants with unclear status were at higher risk of psychological distress than those holding or awaiting a permission. DISCUSSION: In an unselected sample of male asylum seekers and refugees, after around 1 year of resettlement in Italy, the frequency of psychological distress and psychiatric disorders was substantial and clinically relevant. The association between traumatic events, especially post-migration problems, and mental health conditions suggests the need of developing services to assist refugees and asylum seekers to address the multi-faceted problems they experience, such as social support in host country, legal problems concerning permit status and asylum procedure, and family reunification, as well as addressing trauma and mental health issues.

[Osteoporosis and major depression: open debate on a bidirectional relationship]. / La relazione bidirezionale tra osteoporosi e depressione maggiore: un dibattito aperto.

Osteoporosis and depression are two chronic diseases that affect large population groups with great impact on morbidity, mortality and quality of life. Existing studies of the relationship between depression and osteoporosis have been heterogeneous in their design and use of diagnostic instruments for depression, which might have contributed to the different results on the comorbidity of these two conditions. Moreover, the direction of the causative link is still controversial and the etiology remains unclear. Definitely, limited data suggest that osteoporosis may enhance depressive symptoms, while far more studies have shown that depression adversely affects bone density and increases fracture risk. Thus the correlation of these diseases is still under research. This review comments on a plausible causative relationship and underlying mechanisms that might elucidate the link between two very common diseases. We describe the possible impact of osteoporosis on moods and the effect of depression on bone health. In particular, we focus on the role of the hypothalamic-pituitary-adrenocortical and sympathoadrenal axes, of the parathyroid hormone and cytokines. We also describe the effect of the antidepressant drugs as well as lifestyles that may explain this effect.

Acute psychiatric presentation of steroid-responsive encephalopathy: the under recognized side of autoimmune thyroiditis.

Steroid-responsive encephalopathy associated with autoimmune thyroiditis (SREAT), also known as Hashimoto encephalopathy, represents a rare disorder of presumed autoimmune origins that can be diagnosed when a protean variety of psychiatric symptoms are present in association with elevated titers of anti-thyroid antibodies. Symptoms can have a rapid and complete remission with corticosteroid treatment. A 19-year-old girl, with clinical history of Basedow-Graves disease, has been admitted to our department after presenting acute psychiatric symptomatology. Clinical and serological findings were used to formulate the diagnosis of SREAT, confirmed by subsequent positive response to corticosteroid treatment. SREAT can mimic an acute psychiatric symptomatology, thus it seems extremely relevant for psychiatrists to consider this syndrome in differential diagnosis algorithm, especially in those patients presenting a history of autoimmune thyroid disorder, in order to ensure adequate diagnosis and treatment.

[Sensitive delusion of reference, rivisitation of a concept: clinical accounts on onset paranoid psychosis]. / Rivisitazione del concetto di delirio sensitivo: osservazioni cliniche su scompensi paranoicali all'esordio.

AIM: In this work it is discussed whether and how Kretchmer's psychopathological reflections about sensitive delusion of reference can offer a relevant interpretative key for clinicians who face cases of acute persecutory psychosis. It is argued the utility and topicality of those psychopathological concepts that aren't commonly investigated, especially in the evaluation and management of onset paranoid psychosis in an emergency ward. METHODS: We provide clinical vignettes of two young patients, admitted in the emergency psychiatry ward, who represent a concrete example of the dynamic-affective comprehension of delusional elaboration, through its embodiment in the individual biographical development. RESULTS: An interpretative key, based on this specific conceptual frame, seems to provide an integrated intervention tool that aims both to a causal comprehension and demolition of the delusional solution in onset psychotic cases. CONCLUSIONS: The rediscovery of classical psychopathological concepts appears to be a necessary process, especially in the clinical management of onset psychotic disorders. Further and more accurate researches are, in any case, needed.