Intravenous immunoglobulin and rituximab versus placebo treatment of antibody-associated psychosis: study protocol of a randomised phase IIa double-blinded placebo-controlled trial (SINAPPS2)

Abstract: Background: Evidence is conflicting about a causal role of inflammation in psychosis and, specifically, regarding antibodies binding to neuronal membrane targets, especially N-methyl-D-aspartate receptors. NMDAR, LGI1 and GABA-A antibodies were found more prevalent in people with psychosis than in healthy controls. We aim to test whether these antibodies are pathogenic and may cause isolated psychosis. The SINAPPS2 phase IIa double-blinded randomised controlled trial will test the efficacy and safety of immunoglobulin and rituximab treatment versus placebo for patients with acute psychosis symptoms as added to psychiatric standard of care. Methods: We will screen approximately 2500 adult patients with acute psychosis to identify 160 with antibody-positive psychosis without co-existing neurological disease and recruit about 80 eligible participants to the trial in the period from September 2017 to September 2021 across the UK. Eligible patients will be randomised 1:1 either to intravenous immunoglobulin (IVIG) followed by rituximab or to placebo infusions of 1% albumin followed by 0.9% sodium chloride, respectively. To detect a time-to-symptomatic-recovery hazard ratio of 0.322 with a power of 80%, 56 participants are needed to complete the trial, allowing for up to 12 participants to drop out of each group. Eligible patients will be randomised and assessed at baseline within 4 weeks of their eligibility confirmation. The treatment will start with IVIG or 1% albumin placebo infusions over 2–4 consecutive days no later than 7 days from baseline. It will continue 4–5 weeks later with a rituximab or sodium chloride placebo infusion and will end 2–3 weeks after this with another rituximab or placebo infusion. The primary outcome is the time to symptomatic recovery defined as symptomatic remission sustained for at least 6 months on the following Positive and Negative Syndrome Scale items: P1, P2, P3, N1, N4, N6, G5 and G9. Participants will be followed for 12 months from the first day of treatment or, where sustained remission begins after the first 6 months, for an additional minimum of 6 months to assess later response. Discussion: The SINAPPS2 trial aims to test whether immunotherapy is efficacious and safe in psychosis associated with anti-neuronal membrane antibodies. Trial registration: ISRCTN, 11177045. Registered on 2 May 2017. EudraCT, 2016-000118-31. Registered on 22 November 2016. ClinicalTrials.gov, NCT03194815. Registered on 21 June 2017

Bridging Perspectives: Exploring the Convergence of Clinimetrics and Network Theory in Mental Health Assessment and Conceptualization

Background: Clinimetrics and network analysis are two methodological approaches that, despite different origins, share the goal of improving mental health clinical assessment beyond the limitations of classical psychometrics. Despite their common goal and comparable conceptualization of clinical assessment, the potential connection and integration between these approaches has not been explored. The aim of this review is to identify meeting points for the potential integration of clinimetrics and network theory. Methods: A literature review was conducted by examining key works in clinimetrics and network theory and comparing similar concepts from the two approaches. Results: Two main areas of theoretical and methodological convergence and complementarity between clinimetrics and network theory were identified, as follows: the characteristics of clinical indexes and the strategies to assess and organize complex clinical data. These topics encompassed sub-topics related to the influence of individual symptoms on clinical presentation, longitudinal assessment of conditions, influence of comorbidities, and standardized procedures for case formulation. Conclusions: Results provide an indication of the potential for integration for these approaches in a single, clinically oriented methodology for psychological and psychiatric illness conceptualization and assessment. Despite the literature search strategy limitations, the results provide a basis for further exploring the potential for developing an integrated methodology for clinical assessment and treatment planning

Bridging Perspectives: Exploring the Convergence and Combined Potential of Clinimetrics and Network Theory in Mental Health Assessment and Conceptualization

Introduction: Clinimetrics and network analysis are two methodological approaches that, despite different origins, share the goal of improving mental health clinical assessment beyond the limitations of classical psychometrics. Despite their common goal and comparable conceptualization of clinical assessment, the potential connection and integration between these approaches have not been explored. Objective: To identify possible commonalities and potential integration between clinimetrics and network theory. Methods: A theoretical literature review was conducted by manually retrieving and examining key works in both clinimetrics and network theory, isolating, discussing and comparing similar concepts from the two approaches. Results: The review identified and discussed points of theoretical and methodological convergence and complementarity between clinimetrics and network theory in two main topic areas of assessment: characteristics of clinical indexes and strategies to assess and organize complex clinical data. These topics encompassed sub-topics related to the influence of individual symptoms on the clinical presentation, longitudinal assessment of the condition, influence of comorbidities, and standardized procedures for case formulation. Conclusions: The data retrieved provide an indication of the potential integration of clinimetrics and the methodologies of network theory in a single, comprehensive and clinically-oriented approach to psychological and psychiatric illness conceptualization and assessment. Although the limitations of the literature search strategy should be considered, the results presented provide an intriguing initial direction for further exploring this promising research venue to develop a more sophisticated methodology for clinical assessment and treatment planning

Trattato di medicina del lavoro

Dalla Presentazione del Trattato di Francesco S. Violante, Presidente dellla Società Italiana di Medicina del lavoro e Igiene Industriale. Si potrebbe dire che il nuovo trattato di Medicina del Lavoro stia alla trattatistica in lingua italiana del settore come la Encyclopaedia of Occupational Health and Safety sta alla trattatistica in lingua inglese, ovvero come un’opera nella quale lo specialista in Medicina del Lavoro (o la persona comunque interessata a questi temi) può trovare virtualmente un aggiornato ed autorevole riferimento per ogni argomento pertinente. Un trattato però ha anche un altro significato: la sua importanza non si esaurisce con l’inevitabile obsolescenza delle conoscenze scientifiche, perché esso testimonia, nel tempo, qual era lo sviluppo di una disciplina in un determinato periodo storico e non vi è dubbio che, anche negli anni a venire, quest’opera rimarrà come compiuta testimonianza dello sviluppo raggiunto dalla Medicina del Lavoro in Italia, alla metà del secondo decennio del ventunesimo secolo. Il trattato si articola in parti diverse, la prima dedicata alle origini ed evoluzione della Medicina del Lavoro, la seconda che tratta principi, metodi e strumenti della disciplina, la terza che affronta in modo organico la descrizione del sistema nel quale operano i medici del lavoro italiani. La quarta parte del trattato è dedicata ad illustrare in oltre 60 capitoli i diversi fattori di rischio chimici, fisici, biologici e relazionali che si possono incontrare nell’ambiente di vita e di lavoro, mentre la quinta affronta in oltre 40 capitoli le diverse patologie d’interesse del medico del lavoro, nonché gli specifici fattori di rischio che caratterizzano alcuni settori lavorativi come quello sanitario. Il trattato è poi concluso da un originale contributo relativo ai particolari problemi posti al medico del lavoro quando il paziente di cui ci si deve occupare è anch’egli (o anch’ella) un medico. Va lodato lo sforzo dei curatori e degli autori (senza dimenticare la casa editrice) nel realizzare un’opera così complessa (quasi 2000 pagine) che dà accesso, anche a chi non legge l’inglese, ad informazioni autorevoli ed aggiornate praticamente su tutti i temi di interesse per la Medicina del Lavoro: un’opera quindi che non dovrebbe mancare nella biblioteca di ogni specialista (e soprattutto di chi sta studiando per diventarlo) e che si iscrive nella linea della grande trattatistica italiana della Medicina del Lavoro, costituendone l’ultima (nel senso di più aggiornata) pietra miliare

The Psychological and Professional Well-Being of Doctoral Students: Insights from Two Cohorts of a Major Italian University

Although the doctoral path provides a unique opportunity for learning and professional growth, recent research has highlighted a significant prevalence of psychological problems among doctoral students. For this reason, it is crucial to shed light on this issue, understand the factors involved in PhD students' well-being, and inform potential solutions to address the dysfunctional aspects of doctoral programs. This scholarly work presents findings from a comprehensive investigation conducted between 2020 and 2021 among doctoral students from a large Italian University. Based on the Job Demands-Resources Model, we present two studies aimed at identifying the resources and work-related factors associated with psychological and professional well-being outcomes for doctoral students, including anxiety, depression, burnout, and satisfaction with the doctoral program. Study 1 adopted a quantitative approach and involved 243 PhD students surveyed in 2020. Study 2, conducted in 2021 and involving 264 PhD students , further expanded the previous study's findings with a revised quantitative approach, complementing it with a qualitative inquiry. Their results indicate that doctoral students -being outcomes are connected to a combination of structural factors within the doctoral program and relational and psychological aspects. Among the factors examined, the supervisor-student relationship emerged as a significant determinant of many well-being outcomes. Based on these results, the chapter discusses their implications. Awareness-raising and support interventions are suggested to address the challenges experienced by doctoral students and enhance their psychological and professional well-being (e.g., information meetings, awareness campaigns, and help desks), while adopting a collaborative approach, ongoing evaluation, and feedback loops

Staging models in eating disorders: a systematic scoping review of the literature

Eating Disorders (ED) are characterized by low remission rates, drop-out, and residual symptoms despite standardized treatments. To improve assessment and treatment, the staging approach has been proposed. This systematic scoping review is aimed at mapping the existing literature on staging models of ED. A literature search of PubMed, PsycINFO and Scopus was completed using the following terms: staging, anorexia nervosa, bulimia nervosa, binge eating disorders, eating disorders. Nine studies met the inclusion criteria. Eight staging models have been identified, almost all for anorexia nervosa (AN). Only three empirically tested the proposed models. All the models, except one, feature early phases and severe and enduring forms of the illness. Proposed intermediate stages include acute, residual, remission, and relapse phases. The criteria used for the differentiation of stages differ among the models and include behavioral, psychological, cognitive, and medical features; BMI and illness duration were commonly used criteria. In one model, the stages were defined through a standardized measure. Another model identified specific stage-oriented interventions. The current scoping review underscores the need for further empirical studies to operationalize staging in AN and to further explore staging models in BN and BED populations, by paying additional attention to medical features and biomarkers