Efficacy of clozapine versus standard treatment in adult individuals with intellectual disability and treatment-resistant psychosis (CLOZAID): study protocol of a multicenter randomized clinical trial.

Background: Intellectual disability (ID) affects approximately 1% of the worldwide population and individuals with ID have a higher comorbidity with mental illness, and specifically psychotic disorders. Unfortunately, among individuals with ID, limited research has been conducted since ID individuals are usually excluded from mental illness epidemiological studies and clinical trials. Here we perform a clinical trial to investigate the effectiveness of clozapine in the treatment of resistant psychosis in individuals with ID. The article highlights the complexity of diagnosing and treating psychopathological alterations associated with ID and advocates for more rigorous research in this field. Methods: A Phase IIB, open-label, randomized, multicenter clinical trial (NCT04529226) is currently ongoing to assess the efficacy of oral clozapine in individuals diagnosed with ID and suffering from treatment-resistant psychosis. We aim to recruit one-hundred and fourteen individuals (N=114) with ID and resistant psychosis, who will be randomized to TAU (treatment as usual) and treatment-with-clozapine conditions. As secondary outcomes, changes in other clinical scales (PANSS and SANS) and the improvement in functionality, assessed through changes in the Euro-QoL-5D-5L were assessed. The main outcome variables will be analyzed using generalized linear mixed models (GLMM), assessing the effects of status variable (TAU vs. Clozapine), time, and the interaction between them. Discussion: The treatment of resistant psychosis among ID individuals must be directed by empirically supported research. CLOZAID clinical trial may provide relevant information about clinical guidelines to optimally treat adults with ID and treatment-resistant psychosis and the benefits and risks of an early use of clozapine in this underrepresented population in clinical trials. Trial registration: Clinicaltrials.gov: NCT04529226. EudraCT: 2020-000091-37.

The impact of COVID-19 pandemic on the psychological well-being among health care workers: A 6-month cohort longitudinal survey study.

Introduction: Health care workers (HCW) have been identified as a risk group to suffer psychological burden derived from Coronavirus Disease 19 (COVID-19) pandemic. In addition, possible gender differences in the emotional reactions derived from COVID-19 pandemic have been suggested in this population. The aims of the study were to explore the impact of COVID-19 as well as possible gender differences on mental health status and suicidality in a cohort of HCW. Materials and methods: One thousand four hundred and thirty-two HCW responded to an online survey including sociodemographic, clinical, and psychometric tests in May 2020 while 251 HCW answered in November 2020. Mental health status was measured by General Health Questionnaire 28 (GHQ-28) in both time periods. Results: HCW informed of a worsening in somatic symptomatology over the follow up period. Gender differences were found in all GHQ-28 dimensions as well in the total score of the questionnaire. Post hoc analyses displayed significant interaction between the time and gender in somatic and anxiety dimensions as well as in GHQ-28 total score. Stress produced by COVID-19 spreading and the feeling of being overwhelmed at work resulted the main predictors of psychological distress although each domain is characterized by a specific set of predictors. Conclusions: Somatic reactions represent the most sensitive dimension over the follow-up period. Moreover, women are characterized by a greater psychological distress at the beginning, although these differences tend to disappear over time. Finally, a complex network of factors predicted different dimensions of psychological distress, showing the complexity of prevention in high-risk populations facing major disasters.

Introducción: Los trabajadores sanitarios (TS) han sido identificados como un grupo vulnerable de sufrir consecuencias emocionales derivadas de la pandemia causada por la COVID-19. Además, se han sugerido posibles diferencias de género en las reacciones emocionales derivadas del afrontamiento de la pandemia. Los objetivos del estudio fueron explorar el impacto de la COVID-19, así como posibles diferencias de género en las reacciones emociones derivadas de la COVID-19 en una cohorte de TS. Materiales y métodos: Un total de 1.432 TS respondieron a una encuesta en línea que incluía preguntas referidas a datos sociodemográficos, clínicos y psicométricos en mayo de 2020, mientras que 251 TS respondieron en noviembre de 2020. El estado de salud mental se midió mediante el Cuestionario de Salud General 28 (General Health Questionnaire 28 [GHQ-28]) en ambos periodos de tiempo. Resultados: Los TS informaron de un empeoramiento de la sintomatología somática. Se encontraron diferencias de género en todas las dimensiones del GHQ-28. Los análisis post hoc mostraron una interacción significativa entre el tiempo y el género en las dimensiones somáticas y de ansiedad, así como en la puntuación total del GHQ-28. El estrés producido por ser fuente de infección y la sensación de agobio en el trabajo resultaron ser los principales predictores del malestar psicológico, aunque cada dominio se caracteriza por un conjunto específico de predictores. Conclusiones: Las reacciones somáticas representan la dimensión más sensible. Además, las mujeres se caracterizan por un mayor malestar psicológico al principio, aunque estas diferencias tienden a desaparecer con el tiempo. Por último, una compleja red de factores predijo las diferentes dimensiones de la angustia psicológica.

Examining the immune signatures of SARS-CoV-2 infection in pregnancy and the impact on neurodevelopment: Protocol of the SIGNATURE longitudinal study.

The COVID-19 pandemic represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge on pathophysiological mechanisms of neuropsychiatric diseases. One of these opportunities is the study of the relationships between inflammation, brain development and an increased risk of suffering neuropsychiatric disorders. Based on the hypothesis that neuroinflammation during early stages of life is associated with neurodevelopmental disorders and confers a greater risk of developing neuropsychiatric disorders, we propose a cohort study of SARS-CoV-2-infected pregnant women and their newborns. The main objective of SIGNATURE project is to explore how the presence of prenatal SARS-CoV-2 infection and other non-infectious stressors generates an abnormal inflammatory activity in the newborn. The cohort of women during the COVID-19 pandemic will be psychological and biological monitored during their pregnancy, delivery, childbirth and postpartum. The biological information of the umbilical cord (foetus blood) and peripheral blood from the mother will be obtained after childbirth. These samples and the clinical characterisation of the cohort of mothers and newborns, are tremendously valuable at this time. This is a protocol report and no analyses have been conducted yet, being currently at, our study is in the recruitment process step. At the time of this publication, we have identified 1,060 SARS-CoV-2 infected mothers and all have already given birth. From the total of identified mothers, we have recruited 537 SARS-COV-2 infected women and all of them have completed the mental health assessment during pregnancy. We have collected biological samples from 119 mothers and babies. Additionally, we have recruited 390 non-infected pregnant women.