Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia

Abstract BACKGROUND: One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study. METHODS/DESIGN: The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome. DISCUSSION: The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia

The Relationship between PID-5 Personality Traits and Mental States. A Study on a Group of Young Adults at Risk of Psychotic Onset

Background and Objectives: The diagnosis of psychosis is a challenge for the scientific community, both in terms of its definition and treatment. Some recent studies have investigated the relationship between personality and psychosis onset to prevent or intervene early. Materials and Methods: Sixty young adults were recruited during their first access in 2019 near the Community Mental Health Service of Niguarda Hospital, Milan, Italy. The assessment included the Social and Occupational Functioning Assessment Scale (SOFAS), the Global Assessment of Functioning (GAF) (clinician scales), the 16-item Version of the Prodromal Questionnaire (PQ-16), the Personality Inventory for DSM-5 (PID-5) (self-report), and a clinical session. Statistical analysis was performed by SPSS. Results: The results show a negative correlation between the Detachment domain and the GAF scores. Correlational analysis also highlights that all PID-5 domains, except for Antagonism, have positive correlations with high scores in the PQ-16. The multivariate analysis of variance showed that patients diagnosed with versus without a psychotic disorder significantly differed on Detachment, Antagonism and Psychoticism PID-5 domains. Conclusions: The involvement of the personality construct in psychopathological development is displayed. In particular, higher levels of Detachment and Psychoticism can distinguish people who are more vulnerable to psychosis or who already have overt psychosis from those who do not have a psychotic predisposition. The study highlights the fundamental role of personality traits, emerging from PID-5, to distinguish young adults at risk of onset

The Relationship between PID-5 Personality Traits and Mental States. A Study on a Group of Young Adults at Risk of Psychotic Onset

Background and Objectives: The diagnosis of psychosis is a challenge for the scientific community, both in terms of its definition and treatment. Some recent studies have investigated the relationship between personality and psychosis onset to prevent or intervene early. Materials and Methods: Sixty young adults were recruited during their first access in 2019 near the Community Mental Health Service of Niguarda Hospital, Milan, Italy. The assessment included the Social and Occupational Functioning Assessment Scale (SOFAS), the Global Assessment of Functioning (GAF) (clinician scales), the 16-item Version of the Prodromal Questionnaire (PQ-16), the Personality Inventory for DSM-5 (PID-5) (self-report), and a clinical session. Statistical analysis was performed by SPSS. Results: The results show a negative correlation between the Detachment domain and the GAF scores. Correlational analysis also highlights that all PID-5 domains, except for Antagonism, have positive correlations with high scores in the PQ-16. The multivariate analysis of variance showed that patients diagnosed with versus without a psychotic disorder significantly differed on Detachment, Antagonism and Psychoticism PID-5 domains. Conclusions: The involvement of the personality construct in psychopathological development is displayed. In particular, higher levels of Detachment and Psychoticism can distinguish people who are more vulnerable to psychosis or who already have overt psychosis from those who do not have a psychotic predisposition. The study highlights the fundamental role of personality traits, emerging from PID-5, to distinguish young adults at risk of onset.</jats:p

The Relationship between PID-5 Personality Traits and Mental States. A Study on a Group of Young Adults at Risk of Psychotic Onset

Background and Objectives: The diagnosis of psychosis is a challenge for the scientific community, both in terms of its definition and treatment. Some recent studies have investigated the relationship between personality and psychosis onset to prevent or intervene early. Materials and Methods: Sixty young adults were recruited during their first access in 2019 near the Community Mental Health Service of Niguarda Hospital, Milan, Italy. The assessment included the Social and Occupational Functioning Assessment Scale (SOFAS), the Global Assessment of Functioning (GAF) (clinician scales), the 16-item Version of the Prodromal Questionnaire (PQ-16), the Personality Inventory for DSM-5 (PID-5) (self-report), and a clinical session. Statistical analysis was performed by SPSS. Results: The results show a negative correlation between the Detachment domain and the GAF scores. Correlational analysis also highlights that all PID-5 domains, except for Antagonism, have positive correlations with high scores in the PQ-16. The multivariate analysis of variance showed that patients diagnosed with versus without a psychotic disorder significantly differed on Detachment, Antagonism and Psychoticism PID-5 domains. Conclusions: The involvement of the personality construct in psychopathological development is displayed. In particular, higher levels of Detachment and Psychoticism can distinguish people who are more vulnerable to psychosis or who already have overt psychosis from those who do not have a psychotic predisposition. The study highlights the fundamental role of personality traits, emerging from PID-5, to distinguish young adults at risk of onset

Service users perspectives on psychosis-risk terminology: An Italian study on labeling terms preferences and stigma

Aims: The current range of labeling terms-at-risk mental state (ARMS), ultra-high risk for psychosis (UHR), and attenuated psychotic syndrome (APS)-used to refer to the psychosis-risk concept is varied, and their acceptability and potential stigma are not well understood. By involving Italian youth with lived experience of mental ill-health, we aimed to generate new labeling terms for psychosis-risk, and to evaluate literacy, attitudes, and preferences regarding these and the existing terms. Additionally, we investigated opinions of disclosure of the atrisk concept in clinical practice. Methods: Through a dual-moderator focus group, novel diagnostic terms were coined for the at-risk concept: psychosis proneness (PP), change of personal reality (CPR), and hints of subjectivity dysregulation (HSD). A specifically designed questionnaire was then completed by 47 help-seeking youths, 60 relatives, and 61 clinicians to test newly generated and already established at-risk terms. Results: Literacy on already established terms was significantly lower among youth (mean= 42 %) and relatives (mean= 38 %). ARMS was the preferred and least stigmatizing term among young people and clinicians. UHR was considered the most stigmatizing label. Among newly generated terms, CPR was the least stigmatizing and most informative. Disclosure of at-risk terminology was generally preferred after establishing a trusting clinicianpatient relationship. Conclusions: Findings support ARMS as a useful and acceptable term in clinical practice with young people, while UHR is associated with the highest stigma. CPR is promising and should be tested in cross-cultural studies. In Italy, there is an urgent need for improving literacy on prevention in mental health

Are PID-5 personality traits and self-harm attitudes related? A study on a young adult sample pre-post COVID-19 pandemic

Introduction: Different studies confirm a stronger link between maladaptive personality traits and Non-suicidal Self-injury (NSSI). Additionally, the interest in the relationship between the experience of the COVID-19 pandemic and NSSI is growing. The present study aims (a) to investigate differences in personality traits between individuals with NSSI, suicidal ideation, NSSI and suicidal ideation co-occurrence and none; (b) to observe which personality traits predominantly influence the occurrence of self-harm acts; (c) to evaluate the difference in self-harm attitudes pre and post COVID-19 pandemic Method: 270 (108 males and 162 females) participants aged between 18 and 25 were included in the study. Everyone participated in a clinical interview and completed an assessment consisting of the Personality Inventory for DSM-5 (PID-5) and the Health of the Nation Outcome Scales (HoNOS). A multivariate analysis of variance (MANOVA), a multiple hierarchical regression analysis, controlling for age and gender and a T-test for independent samples were conducted. Results: The individuals with the highest levels of negative affectivity, detachment, antagonism, and psychoticism are those who simultaneously present suicidal ideation and NSSI. Moreover, age and detachment predicted higher scores in self-harm attitudes. Our results unexpectedly do not confirm an upward trend of NSSI and suicidal ideation during the pandemic period. Limitations: The study is cross-sectional, and no causal links can be assumed; the groups involved were not homogeneous for numerosity. Conclusions: The results testify that the study of maladaptive traits is fundamental to a greater understanding of NSSIs. Working clinically on those could potentially reduc

Personality traits and transition to psychosis one year after the first assessment

IntroductionSeveral studies have identified ultra-high-risk criteria that may characterize an at-risk mental state and predict the transition of psychotic evolution. Personality traits may play a crucial role in this process.AimsThe current study aims to: (a) explore the evolution of an initial diagnosis over 12 months; (b) assess differences in social and occupational functioning; (c) identify common (trans-diagnostic) personality traits of psychotic risk.MethodsThe sample includes 97 (44 males and 53 females) young adults. They completed an assessment that consists of socio-demographic data, the Social and Occupational Functioning Scale, the Early Recognition Inventory-retrospective assessment onset of schizophrenia, and the Personality Inventory for DSM-5 (PID-5). According to the tests’ assessment, the sample was divided into three different groups: Ultra-High Risk (UHR), At-Risk, and Not at risk. One year after the first evaluation, psychiatrists administered the QuickSCID-5 to verify the diagnostic trajectories of the sample.ResultsOverall, the most prevalent category diagnoses were anxiety/depression, personality disorders, and psychosis. Specifically, the most common diagnosis in the UHR group was psychosis. Moreover, in the UHR group, the social and occupational functioning score was the lowest. In terms of differences in PID-5 personality traits, the At-risk and UHR groups scored highest in detachment and disinhibition. No statistically significant differences were found between the groups for negative affectivity, antagonism, and psychoticism traits.ConclusionResults obtained by the current study should be considered an attempt to better understand the diagnostic trajectories and trans-diagnostic personality traits in a group of young help-seekers, specifically in UHR. Findings highlight both the importance of diagnosis and personality traits evaluation to customize a specific intervention based on the level of psychotic risk. Clinical suggestions are reported