Biomedical subjects

Silvana Galderisi

Publications and source records attributed to Silvana Galderisi.

4 recordsLinked to original sources

PubMed2026

Weight and metabolic changes in patients with schizophrenia treated with paliperidone palmitate 6-month formulation versus paliperidone palmitate 3-month formulation: a post-hoc analysis.

OBJECTIVE: To determine the effect that paliperidone palmitate 6-month long-acting injectable formulation (PP6M) had on metabolic parameters including body weight (BW), and blood lipid profiles, a post-hoc analysis was conducted to assess changes in BW from baseline to the end of study based on age, body mass index (BMI), and changes in blood lipid profiles during a 12-month, phase 3, double-blind (DB) clinical study. Long term effects of PP6M on BW and BMI were further explored during a 24-month extension study in which participants were treated exclusively with PP6M. METHOD: In the 12-month DB phase, participants were randomized to receive PP6M or paliperidone palmitate 3-month long-acting injectable formulation (PP3M). The mean change in BW and abnormal weight percent change from baseline were calculated at endpoint by age, gender, and BMI. Additionally, treatment-emergent shifts from baseline for the four key lipid parameters (fasting low density lipoprotein [LDL], fasting triglycerides [TG], fasting total cholesterol [TC], and fasting high density lipoprotein [HDL]) during DB were assessed. Following this study, participants were given the opportunity to transition to a 24-month extension study and be treated with PP6M. The mean change and percent change in BW, and the mean change in BMI from DB baseline to the end of the extension study (36 months total) were calculated. RESULTS: Participants who were treated with PP6M showed numerically less weight gain, BMI, waist circumference, and more weight decrease compared to PP3M group during 12-month DB phase, though the proportion of participants reporting an abnormal change (≥7% change) in BW did not significantly differ between PP3M and PP6M. The weight differences were more pronounced in the younger age group (18-25 years) and those who were overweight (BMI: 25 to <30 kg/m2. Numerical differences in favor of PP6M were found in fasting blood lipids (HDL, LDL, TG, and TC). The changes in BW and BMI over time remained consistent throughout the 24-month extension, favoring PP6M in each instance. CONCLUSIONS: This post-hoc analysis demonstrated that PP6M was comparable to PP3M in terms of metabolic parameters; however, it may have a beneficial effect on weight gain, especially in young patients. TRIAL REGISTRATION: Post-Hoc Analysis of Studies NCT03345342 and NCT04072575 (ClinicalTrials.gov). Significant outcomes The findings from this study have highlighted that participants who were treated with the 6-month long-acting injectable formulation of paliperidone exhibited less weight gain during treatment overall, and significantly less weight gain in adolescents and young adults. Importantly, this trend continued over the course of long-term treatment, regardless of age. Participants treated with the 6-month formulation also had fewer shifts in blood lipids outside of the normal range and had more favorable changes in body mass index and waist circumference. These results suggest that when considering metabolic dysregulation as a factor in choosing a long-acting injectable antipsychotic, the 6-month formulation is a viable alternative to the 3-month formulation, particularly in younger patients with schizophrenia. Limitations Because this is a post hoc analysis and the study was not powered to test weight and metabolic changes, most endpoints were summarized descriptively and the statistical test was limited to the main endpoint (abnormal percent weight gain and loss).

Adult↗

PubMed2025

Early career psychiatrists' ability to evaluate and manage negative symptoms of schizophrenia - Results from a European survey.

BACKGROUND: Negative symptoms (NS) represent an important unmet need in schizophrenia (SZ) assessment and management. Despite NS are strongly associated with poorer functioning and quality of life, they are frequently underrecognized, inconsistently evaluated, and show limited response to current treatments. Although specific assessment tools and European Psychiatric Association (EPA) guidance on NS have been developed, their impact on routine clinical practice appears limited. This study aimed to investigate the competence and confidence of European Early Career Psychiatrists (ECPs) in NS evaluation and management. METHODS: The CARE project was a cross-sectional online survey directed towards ECPs from European countries. RESULTS: 828 ECPs' responses were collected from 19 countries. The majority of ECPs were trainees (65.8%), reported theoretical training in negative symptoms (NS) and placements in schizophrenia-specialized settings (67.9% and 70.3%), while about half reported extracurricular NS training (51.1%) and involvement in clinical research (46.1%). Only 11% correctly identified NS domains, despite 65.7% felt well-trained in NS assessment tools. Just 15.9% correctly answered questions based on the EPA guidance papers. 46.7% and 25.9% ECPs reported feeling competent in NS evaluation and management, respectively. Gender (men) specialist status, research involvement, theoretical NS training, and placements in specialized SZ services predicted perceived competence. However, in-depth NS knowledge was predicted only by specialist status, engagement in clinical research, and extracurricular NS training. CONCLUSIONS: Despite reported exposure to NS training, ECPs demonstrated limited knowledge of NS. Actions need to be taken to ensure that ECPs receive the highest standard of training in NS.

Humans↗

PubMed2025

Premorbid functioning trajectories and the one-year course of cognitive performance in first-episode psychosis: a cluster analysis in PSYSCAN.

BACKGROUND: We examined the course of cognitive performance in first-episode psychosis (FEP) compared to healthy controls (HC), and whether this varied across subgroups of patients defined by premorbid functioning (PMF) trajectories, using a clustering approach. METHODS: Data were collected in 302 FEP and 136 HC subjects participating in PSYSCAN (HEALTH.2013.2.2.1-2-FEP). K-means clustering (Euclidean distance) was used to cluster longitudinal trajectories of different PMF domains simultaneously. Since PMF was assessed retrospectively using the Premorbid Adjustment Scale (PAS), findings should be interpreted with caution, although PAS ratings have shown reasonable validity against prospective data. RESULTS: As expected, FEP showed impaired performance across all cognitive domains compared to HC. We identified four trajectories of PMF: a normal premorbid developmental trajectory (globally-normal, 21 %), stable intermediate PMF across domains (stable-intermediate, 29 %), stable poor or deteriorating PMF in the academic domain (normal-social/poor-academic, 29 %), and a globally impaired group with poor/deteriorating PMF across domains (globally-poor, 21 %). These clusters showed distinct levels of post-onset impairments in sustained visual attention, visual working memory and emotion recognition. CONCLUSIONS: This study confirms a positive association between PMF and cognitive performance in the early years following psychosis onset. It aligns with findings that individuals later diagnosed with schizophrenia already show developmental deficits/lags from childhood to early adolescence compared to normally developing children. As PMF can be considered a proxy for cognitive reserve, our results suggest that higher reserve acts as a buffer against cognitive decline and supports better performance on sustained visual attention, complex visual working memory, and aspects of emotion recognition.

Clustering↗

PubMed2025

Policy paper of the Committee on Ethics and Task Force on Migration and Mental Health: Migration and mental health of migrants, refugees, asylum seekers - Ethical dilemmas and concerns.

BACKGROUND: International migration is a complex phenomenon of global and historical relevance. It includes voluntary, forced, and workforce migration, shaped by diverse determinants. Push factors comprise war, persecution, and political instability, while pull factors include stability, economic opportunities, education, and favorable living conditions. Forced migration is frequently associated with displacement and a disproportionate burden of mental health disorders, which are urgent yet difficult to address due to structural, cultural, and legal barriers. METHODS: Evidence demonstrates that restricted health care access exacerbates psychiatric disorders, while treatment delays contribute to poorer outcomes. Barriers include administrative limitations, linguistic and cultural differences, stigma, and resource shortages. This policy paper was developed by the Committee on Ethics and the Task Force on Migration and Mental Health of the European Psychiatric Association (EPA). Relevant literature was reviewed and combined with the professional expertise of committee members. The draft was subsequently evaluated by the Publication Committee and the EPA Board, and revised accordingly. RESULTS: Ethical principles in refugee care are insufficiently implemented in many European countries. Core principles of medical ethics - beneficence, respect for autonomy, non-maleficence, and justice - as well as the obligation to advance psychiatric standards and apply psychiatric expertise for societal benefit, are inconsistently upheld. CONCLUSIONS: The primary duty of physicians is to promote health and well-being through competent, timely, and compassionate care. The EPA therefore advocates coordinated strategies to mitigate the mental health consequences of war, displacement, and trauma, and to secure equitable access to psychiatric services for migrants and refugees.

Humans↗