Tag: Mental health

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Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology

IntroductionLecanemab is a monoclonal antibody targeting amyloid-beta (Aβ) approved for treating Alzheimer’s disease (AD) with mild cognitive impairment or mild dementia. Continuous monitoring of its real-world safety profile remains essential. This study aimed to analyze lecanemab-related adverse events (AEs) using the FDA Adverse Event Reporting System (FAERS) database and a multicenter cohort, and explored mechanisms via network pharmacology.MethodsWe conducted an updated disproportionality analysis of FAERS data from 2023 to 2024 to identify disproportionate reporting signals (SDRs). A multicenter retrospective cohort study was performed, including lecanemab users from June 2024 to February 2025. Data were collected from electronic medical records of five tertiary hospitals. AEs were identified and influencing factors of AE occurrence were analyzed. Additionally, a drug-gene interaction network was constructed to explore potential mechanisms.ResultsIn the FAERS analysis of 2,764 AEs from 1,389 lecanemab users, 12 of 41 positive SDRs were prioritized, with 75% (9/12) being nervous system disorders, primarily amyloid-related imaging abnormalities (ARIA). In the cohort study, 29.05% (43/148) of patients experienced AEs, with infusion-related reactions being most common. Age was identified as a risk factor for AE occurrence [OR (95% CI): 1.109 (1.011–1.215), P = 0.028], while pre-treatment significantly reduced AE incidence. Gene enrichment analysis suggested potential links between lecanemab-related genes and AEs.DiscussionThis study provides real-world evidence on the risk profile of lecanemab, highlighting the importance of continued safety monitoring. These findings may inform discussions about the risks associated with anti-amyloid treatments and warrant further confirmation in large-scale prospective studies.
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Disrupted glymphatic function and its relationship with sleep and cognitive impairment in ME/CFS assessed via DTI-ALPS

The glymphatic system is a recently discovered brain waste clearance system that is mostly active during sleep and disengaged during wakefulness. Impaired glymphatic function leads to the deposition of metabolic waste products in the brain potentially causing inflammation leading to various symptoms in ME/CFS. While the glymphatic function has been assessed in other neurodegenerative diseases using ‘diffusion tensor imaging along the perivascular space’ (DTI-ALPS), it has not been studied in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). This preliminary study investigates glymphatic function in 58 participants (ME/CFS = 31 and healthy controls = 27) using the DTI-ALPS index derived from DTI data acquired with 3 T MRI. The bilateral hemispheric DTI-ALPS index was estimated to assess glymphatic function, and an asymmetry index was calculated to determine interhemispheric asymmetry in glymphatic function. We found that the global DTI-ALPS index was significantly lower in ME/CFS patients compared to healthy controls (ME/CFS: 1.44 ± 0.086; healthy controls: 1.51 ± 0.11, p = 0.014), indicating reduced glymphatic function in ME/CFS. Examining the hemispheres separately, showed the right hemisphere DTI-ALPS index was lower in ME/CFS than healthy controls (ME/CFS = 1.41 ± 0.097; healthy controls = 1.49 ± 0.12; p = 0.009) but not different on the left. Additionally, we did not find any significant difference in asymmetry index between ME/CFS and healthy controls. We observed an association between the global DTI-ALPS index and severity of ‘sleep disturbance’ (p = 0.013, r = −0.47) and “impaired concentration” (p = 0.026, r = −0.43). This study demonstrated impaired glymphatic function in ME/CFS which may lead to symptoms such as cognitive dysfunction and sleep disturbance experienced by ME/CFS.
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Burnout and perceived health in medical residents after the COVID-19 pandemic: a single-center cross-sectional study

IntroductionResidents have a high risk of burnout during the training period. The COVID-19 pandemic has had a great impact on work conditions and health of medical residents. We therefore estimated the prevalence of post-pandemic burnout and perceived health, and their relationship with psychosocial factors, stress profile, and job satisfaction, as well as the pre-post pandemic changes.MethodsWe carried out a retrospective cross-sectional, online, anonymous survey using the validated FPSICO-4.0 questionnaire in a teaching hospital after the COVID-19 pandemic (2023). We also studied the pre-post changes from an independent pre-pandemic online survey (2018) with the same tool.ResultsOne hundred ninety-seven residents, 64% females, answered the questionnaire (43.5%); 28% had post-pandemic burnout without gender differences, being higher in surgical specialties (p=0.017) and along residency years (p=0.041). Role performance, behavior stress, job satisfaction and residency years were associated with an increase in odds of burnout (p<0.05). Supervision, conflict of role/cognitive stress explained 35% of the variation in perceived general health (adjusted-R2 = 0.356); temporary autonomy, supervision, information/training/promotion, behavior/somatic stress, and job satisfaction did 68% of mental health (adjusted-R2 = 0.683); and take decisions, conflict of role, behavior/somatic/cognitive stress, and male gender did 62% of vitality (adjusted-R2 = 0.624). Pre/post pandemic mean differences, adjusted by gender and residency year, showed deterioration of variety sense of work (p<0.001), effort of attention (p=0.026), behavior stress (p=0.022), and improvement of temporary autonomy (p=0.045).ConclusionsThe identification after pandemic of high prevalence of burnout, stress levels and certain psychosocial risk factors (role performance and supervision), highlights the need of specific health promotion plan.
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Diagnosis of prolonged grief disorder among older adults: mapping physicians’ knowledge and practice, and evaluating the effectiveness of a brief targeted training program

BackgroundProlonged Grief Disorder (PGD) is a psychiatric diagnosis with significant implications for individuals and society. Familiarity with its diagnostic criteria and recommended interventions is essential for early detection and effective treatment. As aging naturally involves multiple losses, older adults are at distinct risk of developing PGD, a condition associated with psychological and physical comorbidities and increased mortality. In the Israeli context, this issue holds particular significance following the events of October 7, 2023, and the ensuing war, which have had — and continue to have — a profound impact on the population’s mental health. Given PGD’s recent inclusion in diagnostic manuals, many physicians may lack sufficient knowledge, leading to under-recognition or misdiagnosis. This gap is particularly evident among older adults, for whom the assessment and management of psychological distress are often underassessed and undertreated, highlighting the urgent need for targeted training and broader integration of existing knowledge into clinical practice. Accordingly, the present study has two main objectives: (1) to assess physicians’ knowledge and use of PGD diagnostic criteria with older patients, and (2) to evaluate the effectiveness of a brief informational intervention on their understanding and diagnostic application.MethodsUsing a mixed experimental design, the study will include senior physicians and residents specializing in geriatrics, psychiatry, and family medicine. Data will be collected via an online structured questionnaire containing professional background items and clinical vignettes designed to assess participants’ knowledge and application of PGD diagnostic criteria. Afterwards, participants will be individually randomized (1:1) via a computer-generated sequence in a partially participant-blinded, assessor-blinded controlled trial to either an experimental group viewing an informational PGD video or a control group viewing a structurally equivalent video (matched in length, graphics, and word count) addressing bereavement in older adults without directly referencing PGD. All participants will then complete the vignettes again to evaluate the effects of the intervention. A one-month follow-up assessment will evaluate the retention of intervention effects.DiscussionThis first systematic Israeli study on PGD implementation will provide an empirical basis for policy development, professional training, and prevention programs. Its findings may enhance diagnostic accuracy, improve care efficiency, reduce systemic costs, and support ongoing evaluation and refinement of clinical practices.Clinical trial registrationClinicalTrials.gov, identifier NCT07487233.