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1. The interplay between mentalization, personality traits and burnout in psychiatry training: Results from a large multicenter controlled study

Author

Castellini, G, Tarchi, L, Cassioli, E, Ricca, V, Abbate Daga, G, Aguglia, A, Albert, U, Atti, A, Barlati, S, Blasi, G, Carmassi, C, Carra, G, De Fazio, P, De Panfilis, C, Di Lorenzo, G, Ferrari, S, Goracci, A, Gramaglia, C, Luciano, M, Martinotti, G, Menchetti, M, Menculini, G, Nanni, M, Nivoli, A, Pinna, F, Pompili, M, Rosso, G, Sambataro, F, Sampogna, G, Sani, G, Serafini, G, Signorelli, M, Tosato, S, Ventriglio, A, Vigano, C, Volpe, U, Fiorillo, A, Castellini G., Tarchi L., Cassioli E., Ricca V., Abbate Daga G., Aguglia A., Albert U., Atti A., Barlati S., Blasi G., Carmassi C., Carra G., De Fazio P., De Panfilis C., Di Lorenzo G., Ferrari S., Goracci A., Gramaglia C., Luciano M., Martinotti G., Menchetti M., Menculini G., Nanni M. G., Nivoli A., Pinna F., Pompili M., Rosso G., Sambataro F., Sampogna G., Sani G., Serafini G., Signorelli M. S., Tosato S., Ventriglio A., Vigano C., Volpe U., Fiorillo A., Castellini, G, Tarchi, L, Cassioli, E, Ricca, V, Abbate Daga, G, Aguglia, A, Albert, U, Atti, A, Barlati, S, Blasi, G, Carmassi, C, Carra, G, De Fazio, P, De Panfilis, C, Di Lorenzo, G, Ferrari, S, Goracci, A, Gramaglia, C, Luciano, M, Martinotti, G, Menchetti, M, Menculini, G, Nanni, M, Nivoli, A, Pinna, F, Pompili, M, Rosso, G, Sambataro, F, Sampogna, G, Sani, G, Serafini, G, Signorelli, M, Tosato, S, Ventriglio, A, Vigano, C, Volpe, U, Fiorillo, A, Castellini G., Tarchi L., Cassioli E., Ricca V., Abbate Daga G., Aguglia A., Albert U., Atti A., Barlati S., Blasi G., Carmassi C., Carra G., De Fazio P., De Panfilis C., Di Lorenzo G., Ferrari S., Goracci A., Gramaglia C., Luciano M., Martinotti G., Menchetti M., Menculini G., Nanni M. G., Nivoli A., Pinna F., Pompili M., Rosso G., Sambataro F., Sampogna G., Sani G., Serafini G., Signorelli M. S., Tosato S., Ventriglio A., Vigano C., Volpe U., and Fiorillo A.

Abstract

Background: A better characterization of educational processes during psychiatry training is needed, both to foster personal resilience and occupational proficiency. Methods: An adequate coverage of medical residents at the national level was reached (41.86% of the total reference population, 29 out of 36 training centers—80.55%). Controls were recruited among residents in other medical specialties. All participants were assessed by questionnaires to evaluate early life experiences, attachment style, personality traits, coping strategies, emotional competencies. A Structural Equation Model (SEM) framework was employed to investigate the interplay between individual factors. Results: A total sample of 936 people was recruited (87.9% response-rate; 645 residents in psychiatry, 291 other medical residents). Psychiatry trainees reported a higher prevalence of adverse childhood experiences (emotional abuse, emotional neglect, physical neglect), greater attachment insecurity (anxious or avoidant) in comparison to other medical trainees. Psychiatry residents also reported higher social support-seeking as a coping strategy, lower problem-orientation, and lower transcendence. Lower neuroticism, higher openness to experience, and higher emotional awareness were also observed in psychiatry trainees. Psychiatry training was associated with a redefinition of conflict management skills as a function of seniority. The SEM model provided support for an interplay between early traumatic experiences, mentalization skills (coping strategies, emotion regulation), interpersonal competencies and occupational distress. Conclusions: The findings of the present study supported a theoretical model based on mentalization theory for the interactions between personal and relational competencies in psychiatry training, thus providing potential target of remodulation and redefinition of this specific process of education.

Published
2024

3. Interplay between negative symptoms, time spent doing nothing, and negative emotions in patients with schizophrenia spectrum disorders: results from a 37-site study

Author

D'Anna, G, Zarbo, C, Cardamone, G, Zamparini, M, Calza, S, Rota, M, Correll, C, Rocchetti, M, Starace, F, de Girolamo, G, Barlati, S, Baroncelli, A, Besana, F, Boero, M, Clerici, M, Di Michele, V, Durbano, F, Foia, M, Impicci, S, Jacoponi, F, Leuci, E, Malagamba, D, Marina, M, Martinelli, A, Monzani, E, Nappi, G, Piccicacchi, B, Placenti, R, Rippa, A, Tura, G, Zizolfi, S, D'Anna G., Zarbo C., Cardamone G., Zamparini M., Calza S., Rota M., Correll C. U., Rocchetti M., Starace F., de Girolamo G., Barlati S., Baroncelli A., Besana F., Boero M. E., Clerici M., Di Michele V., Durbano F., Foia M. G., Impicci S., Jacoponi F. M., Leuci E., Malagamba D., Marina M., Martinelli A., Monzani E., Nappi G., Piccicacchi B., Placenti R., Rippa A., Tura G., Zizolfi S., D'Anna, G, Zarbo, C, Cardamone, G, Zamparini, M, Calza, S, Rota, M, Correll, C, Rocchetti, M, Starace, F, de Girolamo, G, Barlati, S, Baroncelli, A, Besana, F, Boero, M, Clerici, M, Di Michele, V, Durbano, F, Foia, M, Impicci, S, Jacoponi, F, Leuci, E, Malagamba, D, Marina, M, Martinelli, A, Monzani, E, Nappi, G, Piccicacchi, B, Placenti, R, Rippa, A, Tura, G, Zizolfi, S, D'Anna G., Zarbo C., Cardamone G., Zamparini M., Calza S., Rota M., Correll C. U., Rocchetti M., Starace F., de Girolamo G., Barlati S., Baroncelli A., Besana F., Boero M. E., Clerici M., Di Michele V., Durbano F., Foia M. G., Impicci S., Jacoponi F. M., Leuci E., Malagamba D., Marina M., Martinelli A., Monzani E., Nappi G., Piccicacchi B., Placenti R., Rippa A., Tura G., and Zizolfi S.

Abstract

This study evaluated the relationship between negative symptoms, daily time use (productive/non-productive activities, PA/NPA), and negative emotions in schizophrenia-spectrum disorders (SSDs): 618 individuals with SSDs (311 residential care patients [RCPs], 307 outpatients) were surveyed about socio-demographic, clinical (BPRS, BNSS) and daily time use (paper-and-pencil Time Use Survey completed twice/week) characteristics. Among them 57 RCPs and 46 outpatients, matched to 112 healthy controls, also underwent ecological monitoring of emotions (8 times/day for a week) through Experience Sampling Method (ESM). RCPs spent significantly less time in PA than outpatients. Patients with more negative symptomatology spent more time in NPA and less in PA compared to patients with milder symptoms. Higher time spent in NPA was associated with negative emotions (p < 0.001 during workdays) even when correcting for BNSS total and antipsychotic polypharmacy (p = 0.002 for workdays, p = 0.006 for Sundays). Future studies are needed to explore in more detail the relationship between negative emotions, negative symptoms, time use, and functioning in individuals with SSDs, providing opportunities for more informed and personalised clinical treatment planning and research into interactions between different motivational, saliency and behavioural aspects in individuals with SSDs.

Published
2023

4. Ecological monitoring of physical activity, emotions and daily life activities in schizophrenia: The DiAPAson study

Author

Zarbo, C, Rota, M, Calza, S, Crouter, S, Ekelund, U, Barlati, S, Bussi, R, Clerici, M, Placenti, R, Paulillo, G, Pogliaghi, S, Rocchetti, M, Ruggeri, M, Starace, F, Zanolini, S, Zamparini, M, De Girolamo, G, Zarbo C., Rota M., Calza S., Crouter S. E., Ekelund U., Barlati S., Bussi R., Clerici M., Placenti R., Paulillo G., Pogliaghi S., Rocchetti M., Ruggeri M., Starace F., Zanolini S., Zamparini M., De Girolamo G., Zarbo, C, Rota, M, Calza, S, Crouter, S, Ekelund, U, Barlati, S, Bussi, R, Clerici, M, Placenti, R, Paulillo, G, Pogliaghi, S, Rocchetti, M, Ruggeri, M, Starace, F, Zanolini, S, Zamparini, M, De Girolamo, G, Zarbo C., Rota M., Calza S., Crouter S. E., Ekelund U., Barlati S., Bussi R., Clerici M., Placenti R., Paulillo G., Pogliaghi S., Rocchetti M., Ruggeri M., Starace F., Zanolini S., Zamparini M., and De Girolamo G.

Abstract

Background Schizophrenia spectrum disorders (SSD) compromise psychosocial functioning, including daily time use, emotional expression and physical activity (PA). Objective We performed a cohort study aimed at investigating: (1) the differences in PA, daily activities and emotions between patients with SSD and healthy controls (HC); (2) the strength of the association between these variables and clinical features among patients with SSD. Methods Ninety-nine patients with SSD (53 residential patients, 46 outpatients) and 111 matched HC were assessed for several clinical variables, and levels of functioning by means of standardised clinical measures. Self-reported daily activities and emotions were assessed with a smartphone application for ecological momentary assessment (EMA), and PA levels were assessed with a wearable accelerometer for 7 consecutive days. Findings Patients with SSD, especially those living in residential facilities, spent more time being sedentary, and self-reported more sedentary and self-care activities, experiencing higher levels of negative emotions compared with HC. Moreover, higher functioning levels among patients were associated with more time spent in moderate-to-vigorous activity. Conclusions Sedentary behaviour and negative emotions are particularly critical among patients with SSD and are associated with more impaired clinical outcomes. Clinical implications Mobile-EMA and wearable sensors are useful for monitoring the daily life of patients with SSD and the level of PA. This population needs to be targeted with specific rehabilitative programmes aimed at improving their commitment to structured daily activities.

Published
2023

5. Rumination, posttraumatic stress disorder, and mood symptoms in borderline personality disorder

Author

Dell'Osso L, Cremone IM, Carpita B, Dell'Oste V, Muti D, Massimetti G, Barlati S, Vita A, Fagiolini A, Carmassi C, and Gesi C

Subjects
PTSD, Borderline personality disorder, mood disorders, rumination, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571, Neurology. Diseases of the nervous system, RC346-429
Abstract

Liliana Dell’Osso,1 Ivan M Cremone,1 Barbara Carpita,1 Valerio Dell’Oste,1 Dario Muti,1 Gabriele Massimetti,1 Stefano Barlati,2 Antonio Vita,2 Andrea Fagiolini,3,4 Claudia Carmassi,1 Camilla Gesi11Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; 2Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; 3Department of Mental Health, University of Siena, Siena, Italy; 4Department of Molecular Medicine, University of Siena, Siena, ItalyBackground: The interrelationship between mood disorders and borderline personality disorder (BPD) has been long debated in the literature. Increasing attention has also been paid to the relationship between posttraumatic stress disorder (PTSD) and BPD, as well as to the role of rumination in the development and severity of BPD. This study aims to evaluate the association of rumination, PTSD, and mood spectrum among patients with BPD with or without comorbid mood disorders.Methods: Fifty patients with BPD and 69 healthy controls were assessed with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders 5, MoodSpectrum Self-Report (MOODS-SR), and Ruminative Response Scale (RRS).Results: The BPD group was split into subjects with BPD+ mood disorder (MD) or BPD only) . PTSD-criteria fulfillment, MOODS, and RRS scores were significantly higher in both BPD subgroups than in controls, while BPD+MD patients scored significantly higher than the BPD-only group. RRS scores and PTSD-criteria fulfillment were significantly related to the presence of both BPD and BPD+MD, with no effect of MOODS-SR scores.Conclusion: Our findings confirm the presence of a relationship between BPD and the PTSD spectrum, highlighting also a possible role of rumination in BPD psychopathology. Rumination and PTSD symptoms seem to prevail in the effect of mood spectrum in predicting BPD.Keywords: ruminative thinking, borderline personality disorder, post-traumatic stress disorder, mood disorders

Published
2019

7. Psychiatric rehabilitation patterns in Italy: Results from the Italian Society of Psychosocial Rehabilitation (SIRP) survey

Author

Viganò, C, Ariu, C, Barbieri, D, Goffredi, A, Ferrara, L, Rea, F, Barlati, S, Vita, A, Viganò, Caterina, Ariu, Cassandra, Barbieri, Deborah, Goffredi, Alessia, Ferrara, Luca, Rea, Federico, Barlati, Stefano, Vita, Antonio, Viganò, C, Ariu, C, Barbieri, D, Goffredi, A, Ferrara, L, Rea, F, Barlati, S, Vita, A, Viganò, Caterina, Ariu, Cassandra, Barbieri, Deborah, Goffredi, Alessia, Ferrara, Luca, Rea, Federico, Barlati, Stefano, and Vita, Antonio

Abstract

Introduction: Psychiatric rehabilitation can be considered a bidirectional technique, designed to allow patients to achieve their personal target, focusing on the individuals’ strengths and challenges related to these targets and also on the community organizations in which they will live them out. Unfortunately, psychiatric rehabilitation is too often not considered a first line treatment. Moreover, rehabilitation has been confused with a generic and rough practice, consisting of extemporary actions and aimless entertainments designed to fill “the time passing”. Methods: The aim of this study was to increase the knowledge and awareness about the state of the art of different systems of management and funding of psychosocial rehabilitation in the Italian “real-world” rehabilitative settings, using a specifically developed questionnaire. Results: The data obtained are positive for some aspects of the rehabilitation interventions, in particular for the use of validated tools for the evaluation and revision of projects and for the trend to work on a team, even though the scarcity of evidence-based rehabilitation interventions applied in Italian psychiatric services is less encouraging. Conclusion: This survey presents, at least partially, the “real-world” of rehabilitation in Italy so that we can lay the foundations for the definition of an updated, validated and shared network of what is implemented in the context of psychiatric rehabilitation.

Published
2023

8. Are clinical severity and real-world functioning associated to committing crimes in people with severe mental illness? Results from a cross-sectional study on three cohorts of forensic and non-forensic patients

Author

Calzavara Pinton, I., primary, Stanga, V., additional, Di Noto, M., additional, Butti Lemmi Gigli, E., additional, Cerati, C., additional, Savorelli, A., additional, Necchini, N., additional, Nibbio, G., additional, Deste, G., additional, Barlati, S., additional, Turrina, C., additional, and Vita, A., additional

Published
2023
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9. CYP2D6 and CYP2C19 pharmacogenetic gene variants in major depressive disorder Italian cohort patients

Author

Menesello, V., primary, Pizzoleo, G., additional, Bignotti, S., additional, Perusi, G., additional, Squassina, A., additional, Trabucchi, L., additional, Dattilo, V., additional, Vitali, E., additional, Manchia, M., additional, Tura, G.B., additional, Barlati, S., additional, Bortolomasi, M., additional, Vita, A., additional, Gennarelli, M., additional, and Minelli, A., additional

Published
2023
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10. Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment-resistant depression

Author

Martinotti, G., Dell'Osso, B., Dilorenzo, G., Maina, G., Bertolino, A., Clerici, M., Barlati, S., Rosso, G., Dinicola, M., Marcatili, M., D'Andrea, G., Cavallotto, C., Chiappini, S., Defilippis, S., Nicolo, G., Defazio, P., Andriola, I., Zanardi, R., Nucifora, D., Dimauro, S., Bassetti, R., Pettorruso, M., Mcintyre, R. S., Sensi, S. L., di Giannantonio, M., Vita, A., Baldacci, G., Belletti, S., Bellomo, A., Benatti, B., Carminati, M., Carullo, R., de Berardis, D., de Filippis, R., Chiaie, R. D., di Carlo, F., Di Petta, G., Galluzzo, A., Giorgelli, V., Lombardozzi, G., Martiadis, V., Mattei, C., Mosca, A., Niolu, C., Olivola, M., Percudani, M., Pepe, M., Rossi, E., Scardigli, M. I., Tati, F., Valchera, A., and Vismara, M.

Subjects
Psychiatry and Mental health, bipolar depression, esketamine, pharmacological treatment, rapid-acting antidepressant, treatment-resistant depression, TRD, glutamate, mood disorders, Biological Psychiatry, real-world study
Published
2023

16. EPA guidance on assessment of cognitive impairment in schizophrenia

Author

Vita A., Gaebel W., Mucci A., Sachs G., Erfurth A., Barlati S., Zanca F., Giordano G. M., Glenthoj L. B., Nordentoft M., Galderisi S., Vita, A., Gaebel, W., Mucci, A., Sachs, G., Erfurth, A., Barlati, S., Zanca, F., Giordano, G. M., Glenthoj, L. B., Nordentoft, M., and Galderisi, S.

Subjects
Assessment instrument, Psychotic Disorder, cognitive functioning, high-risk for psychosi, schizophrenia, Cognition Disorder, early psychosi, systematic review, evidence-based, psychosocial functioning, Neuropsychological Test, Schizophrenic Psychology, Cognitive Dysfunction, Human
Abstract

Background. Impairment in a wide range of cognitive abilities has been consistently reported in individuals with schizophrenia. Both neurocognitive and social cognitive deficits are thought to underlie severe functional disabilities associated with schizophrenia. Despite the key role in schizophrenia outcome, cognition is still poorly assessed in both research and clinical settings. Methods. In this guidance paper, we provide a systematic review of the scientific literature and elaborate several recommendations for the assessment of cognitive functions in schizophrenia both in research settings and in real-world clinical practice. Results. Expert consensus and systematic reviews provided guidance for the optimal assessment of cognitive functions in schizophrenia. Based on the reviewed evidence, we recommend a comprehensive and systematic assessment of neurocognitive and social cognitive domains in schizophrenia, in all phases of the disorder, as well as in subjects at risk to develop psychosis. This European Psychiatric Association guidance recommends not only the use of observer reports, but also self-reports and interview-based cognitive assessment tools. The guidance also provides a systematic review of the state of the art of assessment in first episode of psychosis patients and in individuals at risk for psychosis. Conclusion. The comprehensive review of the evidence and the recommendations might contribute to advance the field, allowing a better cognitive assessment, avoiding overlaps with other psychopathological dimensions. The dissemination of this guidance paper may promote the development of shared guidelines concerning the assessment of cognitive functions in schizophrenia, with the purpose to improve the quality of care and to obtain recovery.

Published
2022

17. EPA Guidance on treatment of cognitive impairment in schizophrenia

Author

Vita A., Gaebel W., Mucci A., Sachs G., Barlati S., Giordano G. M., Nibbio G., Nordentoft M., Wykes T., Galderisi S., Vita, A., Gaebel, W., Mucci, A., Sachs, G., Barlati, S., Giordano, G. M., Nibbio, G., Nordentoft, M., Wykes, T., and Galderisi, S.

Subjects
schizophrenia, Antipsychotic Agent, Benzodiazepine, systematic review, treatment, evidence-based, cognitive remediation, Cholinergic Antagonist, Schizophrenic Psychology, Cognitive Dysfunction, cognitive enhancement, Cognitive functioning, Human
Abstract

Background. Although cognitive impairment is a core symptom of schizophrenia related to poorer outcomes in different functional domains, it still remains a major therapeutic challenge. To date, no comprehensive treatment guidelines for cognitive impairment in schizophrenia are implemented. Methods. The aim of the present guidance paper is to provide a comprehensive meta-review of the current available evidence-based treatments for cognitive impairment in schizophrenia. The guidance is structured into three sections: pharmacological treatment, psychosocial interventions, and somatic treatments. Results. Based on the reviewed evidence, this European Psychiatric Association guidance recommends an appropriate pharmacological management as a fundamental starting point in the treatment of cognitive impairment in schizophrenia. In particular, second-generation antipsychotics are recommended for their favorable cognitive profile compared to first generation antipsychotics, although no clear superiority of a single second-generation antipsychotic has currently been found. Anticholinergic and benzodiazepine burden should be kept to a minimum, considering the negative impact on cognitive functioning. Among psychosocial interventions, cognitive remediation and physical exercise are recommended for the treatment of cognitive impairment in schizophrenia. Non-invasive brain stimulation techniques could be taken into account as add on therapy. Conclusion. Overall, there is definitive progress in the field, but further research is needed to develop specific treatments for cognitive impairment in schizophrenia. The dissemination of this guidance paper may promote the development of shared guidelines concerning the treatment of cognitive functions in schizophrenia, with the purpose to improve the quality of care and to achieve recovery in this population.

Published
2022

18. Consequences of the COVID-19 pandemic on admissions to general hospital psychiatric wards in Italy: Reduced psychiatric hospitalizations and increased suicidality

Author

Boldrini, T, Girardi, P, Clerici, M, Conca, A, Creati, C, Di Cicilia, G, Ducci, G, Durbano, F, Maci, C, Maone, A, Nicolo, G, Oasi, O, Percudani, M, Polselli, G, Pompili, M, Rossi, A, Salcuni, S, Tarallo, F, Vita, A, Lingiardi, V, Barlati, S, de Bertoldi, F, Carnaghi, G, Chiesa, G, Dell'Erba, A, Elmo, M, Malvini, L, Monaco, L, Erbuto, D, Pessina, R, Pontillo, M, Riggio, F, Rossi, C, Santorelli, M, Lomoriello, A, Tamorri, S, Venturini, P, Vicari, S, Boldrini T., Girardi P., Clerici M., Conca A., Creati C., Di Cicilia G., Ducci G., Durbano F., Maci C., Maone A., Nicolo G., Oasi O., Percudani M., Polselli G. M., Pompili M., Rossi A., Salcuni S., Tarallo F., Vita A., Lingiardi V., Barlati S., de Bertoldi F., Carnaghi G., Chiesa G. L., Dell'Erba A., Elmo M. G., Malvini L., Monaco L., Erbuto D., Pessina R. L., Pontillo M., Riggio F., Rossi C., Santorelli M., Lomoriello A. S., Tamorri S. M., Venturini P., Vicari S., Boldrini, T, Girardi, P, Clerici, M, Conca, A, Creati, C, Di Cicilia, G, Ducci, G, Durbano, F, Maci, C, Maone, A, Nicolo, G, Oasi, O, Percudani, M, Polselli, G, Pompili, M, Rossi, A, Salcuni, S, Tarallo, F, Vita, A, Lingiardi, V, Barlati, S, de Bertoldi, F, Carnaghi, G, Chiesa, G, Dell'Erba, A, Elmo, M, Malvini, L, Monaco, L, Erbuto, D, Pessina, R, Pontillo, M, Riggio, F, Rossi, C, Santorelli, M, Lomoriello, A, Tamorri, S, Venturini, P, Vicari, S, Boldrini T., Girardi P., Clerici M., Conca A., Creati C., Di Cicilia G., Ducci G., Durbano F., Maci C., Maone A., Nicolo G., Oasi O., Percudani M., Polselli G. M., Pompili M., Rossi A., Salcuni S., Tarallo F., Vita A., Lingiardi V., Barlati S., de Bertoldi F., Carnaghi G., Chiesa G. L., Dell'Erba A., Elmo M. G., Malvini L., Monaco L., Erbuto D., Pessina R. L., Pontillo M., Riggio F., Rossi C., Santorelli M., Lomoriello A. S., Tamorri S. M., Venturini P., and Vicari S.

Abstract

Aims: The present investigation aimed at evaluating differences in psychiatric hospitalizations in Italy during and after the lockdown due to the novel coronavirus disease 2019 (COVID-19), compared to the same periods in 2018 and 2019. Methods: We obtained and analyzed anonymized data on psychiatric admissions (n = 4550) from 12 general hospital psychiatric wards (GHPWs) in different Italian regions (catchment area = 3.71 millions of inhabitants). Using a mixed-effects Poisson regression model, we compared admission characteristics across three periods: (a) March 1–June 30, 2018 and 2019; (b) March 1–April 30, 2020 (i.e., lockdown); and (c) May 1–June 30, 2020 (i.e., post-lockdown). Results: During the COVID-19 lockdown, there was a 41% reduction (IRR = 0.59; p < 0.001, CI: 0.45–0.79) in psychiatric admissions in the enrolled GHPWs with respect to the 2018 and 2019 control period. Conversely, admission rates in the post-lockdown period were similar to those observed in the control period. Notably, a consistent and significant reduction in psychiatric hospitalizations of older patients (aged >65 years) was observed in the lockdown (40%; IRR = 0.60; 95% CI: 0.44–0.82) and post-lockdown (28%; IRR = 0.72; 95% CI: 0.54–0.96) periods. Long-stay admissions (>14 days) increased (63%; IRR = 1.63; 95% CI: 1.32–2.02) during the lockdown and decreased by 39% thereafter (IRR = 0.61; 95% CI: 0.49–0.75). A significant 35% increase in patients reporting suicidal ideation was observed in the post-lockdown period, compared to the rate observed in the 2018 and 2019 control period (IRR = 1.35; 95% CI: 1.01–1.79). Conclusion: The COVID-19 lockdown was associated with changes in the number of psychiatric admissions, particularly for older patients and long-stay hospitalizations. Increased admission of patients reporting suicidal ideation in the post-lockdown period merits special attention. Further studies are required to gain insight into the observed phenomena.

Published
2021

22. Genome-wide association study detected novel susceptibility genes for social cognition impairment in people with schizophrenia

Author

Gennarelli, M., Monteleone, P., Minelli, A., Monteleone, A. M., Rossi, A., Rocca, P., Bertolino, A., Aguglia, E., Amore, M., Bellino, S., Bellomo, A., Biondi, M., Bucci, P., Carpiniello, B., Cascino, G., Cuomo, A., Dell'Osso, L., di Giannantonio, M., Giordano, G. M., Marchesi, C., Oldani, L., Pompili, M., Roncone, R., Rossi, R., Siracusano, A., Tenconi, E., Vita, A., Zeppegno, P., Galderisi, S., Maj, M., Corrivetti, G., Del Buono, G., Torretta, S., Calia, V., Raio, A., Barlati, S., Deste, G., Magri, C., Valsecchi, P., Pinna, F., Muscas, M., Marras, L., Piegari, G., Giuliani, L., Brando, F., Coccia, C., Concerto, C., Poli, L. F., Surace, T., Martinotti, G., Pettorruso, M., Fraticelli, S., Altamura, M., Pasquale Tortorelli, F. M., Mollica, A., Calcagno, P., Murri, M. B., Serafini, G., Pacitti, F., Socci, V., Lucaselli, A., Giusti, L., Mammarella, S., Bianchini, V., Gramaglia, C., Gambaro, E., Martelli, M., Favaro, A., Meneguzzo, P., Collantoni, E., Tonna, M., Ossola, P., Gerra, M. L., Carmassi, C., Carpita, B., Cremone, I. M., Comparelli, A., Brugnoli, R., Corigliano, V., Fagiolini, A., Bolognesi, S., Goracci, A., Di Lorenzo, G., Ribolsi, M., Niolu, C., Bozzatello, P., Brasso, C., Montemagni, C., Buzzanca, A., Di Fabio, F., Girardi, N., Gennarelli, Massimo, Monteleone, Palmiero, Minelli, Alessandra, Monteleone, Alessio Maria, Rossi, Alessandro, Rocca, Paola, Bertolino, Alessandro, Aguglia, Eugenio, Amore, Mario, Bellino, Silvio, Bellomo, Antonello, Biondi, Massimo, Bucci, Paola, Carpiniello, Bernardo, Cascino, Giammarco, Cuomo, Alessandro, Dell'Osso, Liliana, di Giannantonio, Massimo, Giordano, Giulia Maria, Marchesi, Carlo, Oldani, Lucio, Pompili, Maurizio, Roncone, Rita, Rossi, Rodolfo, Siracusano, Alberto, Tenconi, Elena, Vita, Antonio, Zeppegno, Patrizia, Galderisi, Silvana, and Maj, Mario

Subjects
Treatment outcome, GWAS, Social cognition, TMEM74, meta-analysis, schizophrenia, Genetic Predisposition to Disease, Genome-Wide Association Study, Humans, Membrane Proteins, Polymorphism, Single Nucleotide, Schizophrenia, Social Cognition, Susceptibility gene, Genome-wide association study, Biology, Affect (psychology), meta-analysi, 03 medical and health sciences, 0302 clinical medicine, medicine, SNP, Polymorphism, Biological Psychiatry, Genetics, Single Nucleotide, medicine.disease, 030227 psychiatry, Psychiatry and Mental health, Settore MED/25, Meta-analysis
Abstract

Objectives People with schizophrenia (SCZ) present serious and generalised deficits in social cognition (SC), which affect negatively patients' functioning and treatment outcomes. The genetic background of SC has been investigated in disorders other than SCZ providing weak and sparse results. Thus, our aim was to explore possible genetic correlates of SC dysfunctions in SCZ patients with a genome-wide study (GWAS) approach. Methods We performed a GWAS meta-analysis of data coming from two cohorts made of 242 and 160 SCZ patients, respectively. SC was assessed with different tools in order to cover its different domains. Results We found GWAS significant association between the TMEM74 gene and the patients' ability in social inference as assessed by The Awareness of Social Inference Test; this association was confirmed by both SNP-based analysis (lead SNP rs3019332 p-value = 5.24 × 10-9) and gene-based analysis (p-value = 1.09 × 10-7). Moreover, suggestive associations of other genes with different dimensions of SC were also found. Conclusions Our study shows for the first time GWAS significant or suggestive associations of some gene variants with SC domains in people with SCZ. These findings should stimulate further studies to characterise the genetic underpinning of SC dysfunctions in SCZ.

Published
2022

23. Area 2. Attività ed Interventi in RPS

Author

Francomano, A., Viganò, C., Ariu, S., Barlati, S., Brando, F., De Angelis, M., Ferrara, L, Giordano, G. M., Lo Duca, S., Suarez, J., Volpe, U., Zotos, S., Corso, M., Dazzo, M., De Fazio, P., Ferrara, D., Gentile, S., Gurzì, A., Landi, S., Merlotti, E., Messina, M., Piazza, F., Riccardo, C., Semisa, D., Mucci, A., and Roncone, R.

Published
2022

24. The Relationship between mental pain, suicide risk, and childhood traumatic experiences

Author

Pompili, M, Erbuto, D, Innamorati, M, Luciano, M, Sampogna, G, Abbate-Daga, G, Barlati, S, Carmassi, C, Castellini, G, Fazio, Pd, Di Lorenzo, G, Nicola, Md, Ferrari, S, Gramaglia, C, Nanni, Mg, Pasquini, M, Pinna, F, Poloni, N, Serafini, G, Signorelli, M, Ventriglio, A, Volpe, U, and Fiorillo, A

Subjects
Settore MED/25
Published
2022

27. The influence of autistic symptoms on social and non-social cognition and on real-life functioning in people with schizophrenia: Evidence from the Italian Network for Research on Psychoses multicenter study

Author

Vita, A., Barlati, S., Deste, G., Rocca, P., Rossi, A., Bertolino, A., Aguglia, E., Amore, M., Bellomo, A., Biondi, M., Carpiniello, B., Collantoni, E., Cuomo, A., D'Ambrosio, E., dell' Osso, L., di Giannantonio, M., Giordano, G. M., Marchesi, C., Monteleone, P., Montemagni, C., Oldani, L., Pompili, M., Roncone, R., Rossi, R., Siracusano, A., Zeppegno, P., Nibbio, G., Galderisi, S., Maj, M., Ceraso, A., Galluzzo, A., Lisoni, J., Di Palo, P., Papalino, M., Romano, R., Pinna, F., Lai, A., di Santa Sofia, S. L., Bucci, P., Piegari, G., Brando, F., Giuliani, L., Signorelli, M. S., Poli, L. F., Martinotti, G., Pettorruso, M., Montemitro, C., Altamura, M., Malerba, S., Padalino, F., Amerio, A., Cal-Cagno, P., Zampogna, D., Giusti, L., Salza, A., Mammarella, S., Pacitti, F., Socci, V., Talevi, D., Gramaglia, C., Feggi, A., Jona, A., Favaro, A., Tenconi, E., Meneguzzo, P., Ossola, P., Tonna, M., Gerra, M. L., Carmassi, C., Gesi, C., Carpita, B., Corrivetti, G., Cascino, G., del Buono, G., Di Fabio, F., Buzzanca, A., Girardi, N., Brugnoli, R., Comparelli, A., Corigliano, V., Fagiolini, A., Bolognesi, S., Goracci, A., Di Lorenzo, G., Niolu, C., Ribolsi, M., Brasso, C., Riccardi, C., Del Favero, E., Vita, A., Barlati, S., Deste, G., Rocca, P., Rossi, A., Bertolino, A., Aguglia, E., Amore, M., Bellomo, A., Biondi, M., Carpiniello, B., Collantoni, E., Cuomo, A., D'Ambrosio, E., dell' Osso, L., di Giannantonio, M., Giordano, G. M., Marchesi, C., Monteleone, P., Montemagni, C., Oldani, L., Pompili, M., Roncone, R., Rossi, R., Siracusano, A., Zeppegno, P., Nibbio, G., Galderisi, S., Maj, M., Ceraso, A., Galluzzo, A., Lisoni, J., Di Palo, P., Papalino, M., Romano, R., Pinna, F., Lai, A., di Santa Sofia, S. L., Bucci, P., Piegari, G., Brando, F., Giuliani, L., Signorelli, M. S., Poli, L. F., Martinotti, G., Pettorruso, M., Montemitro, C., Altamura, M., Malerba, S., Padalino, F., Amerio, A., Cal-Cagno, P., Zampogna, D., Giusti, L., Salza, A., Mammarella, S., Pacitti, F., Socci, V., Talevi, D., Gramaglia, C., Feggi, A., Jona, A., Favaro, A., Tenconi, E., Meneguzzo, P., Ossola, P., Tonna, M., Gerra, M. L., Carmassi, C., Gesi, C., Carpita, B., Corrivetti, G., Cascino, G., del Buono, G., Di Fabio, F., Buzzanca, A., Girardi, N., Brugnoli, R., Comparelli, A., Corigliano, V., Fagiolini, A., Bolognesi, S., Goracci, A., Di Lorenzo, G., Niolu, C., Ribolsi, M., Brasso, C., Riccardi, C., and Del Favero, E.

Subjects
schizophrenia, autism spectrum disorders, cognition, psychosocial functioning, social cognition, Adult, Male, Social Cognition, Interpersonal Relation, autism spectrum disorders, cognition, psychosocial functioning, schizophrenia, social cognition, Disease, Autism spectrum disorders, Cognition, Psychosocial functioning, Schizophrenia, Social cognition, Psychotic Disorder, behavioral disciplines and activities, 03 medical and health sciences, Interpersonal relationship, 0302 clinical medicine, mental disorders, Medicine, Humans, Interpersonal Relations, Autism spectrum disorder, Autistic Disorder, business.industry, medicine.disease, 030227 psychiatry, Psychiatry and Mental health, Multicenter study, Settore MED/25, Italy, Psychotic Disorders, Autism, Female, Verbal memory, business, 030217 neurology & neurosurgery, Research Article, Clinical psychology, Human
Abstract

Background Autism spectrum disorders (ASDs) and schizophrenia spectrum disorders (SSDs), although conceptualized as separate entities, may share some clinical and neurobiological features. ASD symptoms may have a relevant role in determining a more severe clinical presentation of schizophrenic disorder but their relationships with cognitive aspects and functional outcomes of the disease remain to be addressed in large samples of individuals. Aims To investigate the clinical, cognitive, and functional correlates of ASD symptoms in a large sample of people diagnosed with schizophrenia. Methods The severity of ASD symptoms was measured with the PANSS Autism Severity Scale (PAUSS) in 921 individuals recruited for the Italian Network for Research on Psychoses multicenter study. Based on the PAUSS scores, three groups of subjects were compared on a wide array of cognitive and functional measures. Results Subjects with more severe ASD symptoms showed a poorer performance in the processing speed (p = 0.010), attention (p = 0.011), verbal memory (p = 0.035), and social cognition (p = 0.001) domains, and an overall lower global cognitive composite score (p = 0.010). Subjects with more severe ASD symptoms also showed poorer functional capacity (p = 0.004), real-world interpersonal relationships (p p Conclusions These findings strengthen the notion that ASD symptoms may have a relevant impact on different aspects of the disease, crucial to the life of people with schizophrenia. Prominent ASD symptoms may characterize a specific subpopulation of individuals with SSD.

Published
2020

28. Factors Associated With Real-Life Functioning in Persons With Schizophrenia in a 4-Year Follow-up Study of the Italian Network for Research on Psychoses

Author

Mucci, A., Galderisi, S., Gibertoni, D., Rossi, A., Rocca, P., Bertolino, A., Aguglia, E., Amore, M., Bellomo, A., Biondi, M., Blasi, G., Brasso, C., Bucci, P., Carpiniello, B., Cuomo, A., Dell'Osso, L., Giordano, G. M., Marchesi, C., Monteleone, P., Niolu, C., Oldani, L., Pettorruso, M., Pompili, M., Roncone, R., Rossi, R., Tenconi, E., Vita, A., Zeppegno, P., Maj, M., Piegari, G., Aiello, C., Brando, F., Giuliani, L., Palumbo, D., Coccia, C., Papalino, M., Calia, V., Romano, R., Barlati, S., Deste, G., Valsecchi, P., Pinna, F., Lai, A., Lostia di Santa Sofia, S., Salvina Signorelli, M., Fusar Poli, L., Surace, T., Martinotti, G., Montemitro, C., Fraticelli, S., Altamura, M., Angelini, E., Elia, A., Calcagno, P., Belvederi Murri, M., Cattedra, S., Pacitti, F., Talevi, D., Socci, V., Giusti, L., Salza, A., Mammarella, S., de Bartolomeis, A., Favaro, A., Collantoni, E., Meneguzzo, P., Tonna, M., Ossola, P., Gerra, M. L., Gramaglia, C., Binda, V., Gambaro, E., Carmassi, C., Carpita, B., Cremone, I. M., Corrivetti, G., Cascino, G., Del Buono, G., Brugnoli, R., Comparelli, A., Corigliano, V., Buzzanca, A., Gerardi, N., Frascarelli, M., Fagiolini, A., Goracci, A., Bolognesi, S., Siracusano, A., Di Lorenzo, G., Ribolsi, M., Montemagni, C., Riccardi, C., Del Favero, E., Mucci, A., Galderisi, S., Gibertoni, D., Rossi, A., Rocca, P., Bertolino, A., Aguglia, E., Amore, M., Bellomo, A., Biondi, M., Blasi, G., Brasso, C., Bucci, P., Carpiniello, B., Cuomo, A., Dell'Osso, L., Giordano, G. M., Marchesi, C., Monteleone, P., Niolu, C., Oldani, L., Pettorruso, M., Pompili, M., Roncone, R., Rossi, R., Tenconi, E., Vita, A., Zeppegno, P., Maj, M., Mucci A., Galderisi S., Gibertoni D., Rossi A., Rocca P., Bertolino A., Aguglia E., Amore M., Bellomo A., Biondi M., Blasi G., Brasso C., Bucci P., Carpiniello B., Cuomo A., Dell'Osso L., Giordano G.M., Marchesi C., Monteleone P., Niolu C., Oldani L., Pettorruso M., Pompili M., Roncone R., Rossi R., Tenconi E., Vita A., Zeppegno P., and Maj M.

Subjects
Adult, Hospitals, Psychiatric, Male, Mental Health Services, Social Cognition, Apathy, Psychological intervention, Relapse prevention, schizophrenia, functioning, psychopatology, Structural equation modeling, 03 medical and health sciences, 0302 clinical medicine, Medicine, Humans, Cognitive Dysfunction, Female, Follow-Up Studies, Independent Living, Italy, Middle Aged, Psychotic Disorders, Schizophrenia, Functional Status, Original Investigation, business.industry, Mental health, Hospitals, Cognitive training, 030227 psychiatry, Psychiatry and Mental health, Settore MED/25, schizophrenia, real-life functioning, SEM, Psychiatric, Work Skills, business, Psychosocial, 030217 neurology & neurosurgery, Psychopathology, Clinical psychology
Abstract

Importance: The goal of schizophrenia treatment has shifted from symptom reduction and relapse prevention to functional recovery; however, recovery rates remain low. Prospective identification of variables associated with real-life functioning domains is essential for personalized and integrated treatment programs. Objective: To assess whether baseline illness-related variables, personal resources, and context-related factors are associated with work skills, interpersonal relationships, and everyday life skills at 4-year follow-up. Design, Setting, and Participants: This multicenter prospective cohort study was conducted across 24 Italian university psychiatric clinics or mental health departments in which 921 patients enrolled in a cross-sectional study were contacted after 4 years for reassessment. Recruitment of community-dwelling, clinically stable persons with schizophrenia was conducted from March 2016 to December 2017, and data were analyzed from January to May 2020. Main Outcomes and Measures: Psychopathology, social and nonsocial cognition, functional capacity, personal resources, and context-related factors were assessed, with real-life functioning as the main outcome. Structural equation modeling, multiple regression analyses, and latent change score modeling were used to identify variables that were associated with real-life functioning domains at follow-up and with changes from baseline in these domains. Results: In total, 618 participants (427 male [69.1%]; mean [SD] age, 45.1 [10.5] years) were included. Five baseline variables were directly associated with real-life functioning at follow-up: neurocognition with everyday life (β, 0.274; 95% CI, 0.207-0.341; P

Published
2021

29. Prevalence of antipsychotic-induced extrapyramidal symptoms and their association with neurocognition and social cognition in outpatients with schizophrenia in the 'real-life'

Author

Monteleone, P., Cascino, G., Monteleone, A. M., Rocca, P., Rossi, A., Bertolino, A., Aguglia, E., Amore, M., Collantoni, E., Corrivetti, G., Cuomo, A., Bellomo, A., D'Ambrosio, E., Dell'Osso, L., Frascarelli, M., Giordano, G. M., Giuliani, L., Marchesi, C., Montemagni, C., Oldani, L., Pinna, F., Pompili, M., Roncone, R., Rossi, R., Siracusano, A., Vita, A., Zeppegno, P., Galderisi, S., Maj, M., Del Buono, G., Marciello, F., Di Palo, P., Sangiuliano, M., Di Gioia, C., Barlati, S., Deste, G., Turrina, C., Carpiniello, B., Marras, L., Muscas, M., Bucci, P., Piegari, G., Brando, F., Aiello, C., Poli, L. F., Saitta, G., Surace, T., Altamura, M., Malerba, S., Padalino, F., Calcagno, P., Murri, M. B., Escelsior, A., Giusti, L., Bianchini, V., Salza, A., Pacitti, F., Socci, V., Lucaselli, A., De Bartolomeis, A., Gramaglia, C., Feggi, A., Jona, A., Favaro, A., Tenconi, E., Meneguzzo, P., Ossola, P., Tonna, M., Gerra, M. L., Carmassi, C., Cremone, I. M., Carpita, B., Biondi, M., Di Fabio, F., Accinni, T., Brugnoli, R., Comparelli, A., Corigliano, V., Fagiolini, A., Bolognesi, S., Goracci, A., Di Lorenzo, G., Ribolsi, M., Niolu, C., Brasso, C., Riccardi, C., Del Favero, E., Monteleone, P., Cascino, G., Monteleone, A. M., Rocca, P., Rossi, A., Bertolino, A., Aguglia, E., Amore, M., Collantoni, E., Corrivetti, G., Cuomo, A., Bellomo, A., D'Ambrosio, E., Dell'Osso, L., Frascarelli, M., Giordano, G. M., Giuliani, L., Marchesi, C., Montemagni, C., Oldani, L., Pinna, F., Pompili, M., Roncone, R., Rossi, R., Siracusano, A., Vita, A., Zeppegno, P., Galderisi, S., and Maj, M.

Subjects
Adult, Male, Social Cognition, Extrapyramidal symptoms, Chlorpromazine, medicine.medical_treatment, Antipsychotic, 03 medical and health sciences, 0302 clinical medicine, Cognition, Basal Ganglia Diseases, Social cognition, Prevalence, Medicine, Antipsychotics, Humans, Extrapyramidal symptom, Neurocognition, Biological Psychiatry, Pharmacology, business.industry, Parkinsonism, Middle Aged, medicine.disease, Risperidone, 030227 psychiatry, Settore MED/25, Schizophrenia, Female, Schizophrenic Psychology, medicine.symptom, business, Neurocognitive, Antipsychotic Agents, Psychopathology, Clinical psychology
Abstract

First generation antipsychotics (FGAs) are more likely to induce extrapyramidal side-effects (EPS) than second generation antipsychotics (SGAs), and EPS have been shown associated to cognitive deficits in schizophrenia. So far, no study has explored the relationships between EPS and social cognition (SC) in people with schizophrenia. Therefore, we assessed the prevalence of EPS in a large sample of drug-treated community-dwelling persons with schizophrenia and explored their relationships with patients' neurocognitive and SC abilities. 875 patients underwent EPS, psychopathological, neurocognitive and SC assessments by means of standardized measures. Relationships between EPS, psychopathology and neurocognitive and SC measures were investigated by correlation tests. Moreover, a partial correlation network was computed by means of a network analysis. 256 patients were treated with FGAs alone or in combination with SGA and 619 with SGAs. EPS were significantly more frequent in FGA-treated group than in the SGA-treated one. Patients with EPS disclosed a more severe psychopathology and were more impaired in neurocognitive and SC measures compared to those without EPS. Disorganization, expressive deficit, and duration of illness were significantly associated to both neurocognitive and SC measures while EPS were associated to neurocognitive measures only. The network analysis showed that parkinsonism was the sole EPS directly connected to both psychopathological and neurocognitive indices whereas no direct connection emerged between EPS and SC measures. Present findings confirm that EPS are still present in the era of SGAs and contribute, together with other clinical variables, to the neurocognitive but not to the SC impairment of patients with schizophrenia.

Published
2021

30. Consequences of the COVID-19 pandemic on admissions to general hospital psychiatric wards in Italy: Reduced psychiatric hospitalizations and increased suicidality

Author

Boldrini, Marco Tobia Mario, Girardi, P., Clerici, Anna Marina, Conca, A., Creati, C., Di Cicilia, G., Ducci, G., Durbano, F., Maci, C., Maone, A., Nicolo, G., Oasi, Osmano, Percudani, M., Polselli, G. M., Pompili, M., Rossi, A., Salcuni, S., Tarallo, F., Vita, A., Lingiardi, Vittorio, Barlati, S., de Bertoldi, F., Carnaghi, G., Chiesa, G. L., Dell'Erba, A., Elmo, M. G., Malvini, Lara, Monaco, L., Erbuto, D., Pessina, R. L., Pontillo, M., Riggio, F., Rossi, Chiara, Santorelli, M., Lomoriello, A. S., Tamorri, S. M., Venturini, P., Vicari, Stefano, Boldrini T., Clerici M., Oasi O. (ORCID:0000-0003-2134-397X), Lingiardi V., Malvini L., Rossi C. (ORCID:0000-0002-3570-2710), Vicari S. (ORCID:0000-0002-5395-2262), Boldrini, Marco Tobia Mario, Girardi, P., Clerici, Anna Marina, Conca, A., Creati, C., Di Cicilia, G., Ducci, G., Durbano, F., Maci, C., Maone, A., Nicolo, G., Oasi, Osmano, Percudani, M., Polselli, G. M., Pompili, M., Rossi, A., Salcuni, S., Tarallo, F., Vita, A., Lingiardi, Vittorio, Barlati, S., de Bertoldi, F., Carnaghi, G., Chiesa, G. L., Dell'Erba, A., Elmo, M. G., Malvini, Lara, Monaco, L., Erbuto, D., Pessina, R. L., Pontillo, M., Riggio, F., Rossi, Chiara, Santorelli, M., Lomoriello, A. S., Tamorri, S. M., Venturini, P., Vicari, Stefano, Boldrini T., Clerici M., Oasi O. (ORCID:0000-0003-2134-397X), Lingiardi V., Malvini L., Rossi C. (ORCID:0000-0002-3570-2710), and Vicari S. (ORCID:0000-0002-5395-2262)

Abstract

Aims: The present investigation aimed at evaluating differences in psychiatric hospitalizations in Italy during and after the lockdown due to the novel coronavirus disease 2019 (COVID-19), compared to the same periods in 2018 and 2019. Methods: We obtained and analyzed anonymized data on psychiatric admissions (n = 4550) from 12 general hospital psychiatric wards (GHPWs) in different Italian regions (catchment area = 3.71 millions of inhabitants). Using a mixed-effects Poisson regression model, we compared admission characteristics across three periods: (a) March 1–June 30, 2018 and 2019; (b) March 1–April 30, 2020 (i.e., lockdown); and (c) May 1–June 30, 2020 (i.e., post-lockdown). Results: During the COVID-19 lockdown, there was a 41% reduction (IRR = 0.59; p < 0.001, CI: 0.45–0.79) in psychiatric admissions in the enrolled GHPWs with respect to the 2018 and 2019 control period. Conversely, admission rates in the post-lockdown period were similar to those observed in the control period. Notably, a consistent and significant reduction in psychiatric hospitalizations of older patients (aged >65 years) was observed in the lockdown (40%; IRR = 0.60; 95% CI: 0.44–0.82) and post-lockdown (28%; IRR = 0.72; 95% CI: 0.54–0.96) periods. Long-stay admissions (>14 days) increased (63%; IRR = 1.63; 95% CI: 1.32–2.02) during the lockdown and decreased by 39% thereafter (IRR = 0.61; 95% CI: 0.49–0.75). A significant 35% increase in patients reporting suicidal ideation was observed in the post-lockdown period, compared to the rate observed in the 2018 and 2019 control period (IRR = 1.35; 95% CI: 1.01–1.79). Conclusion: The COVID-19 lockdown was associated with changes in the number of psychiatric admissions, particularly for older patients and long-stay hospitalizations. Increased admission of patients reporting suicidal ideation in the post-lockdown period merits special attention. Further studies are required to gain insight into the observed phenomena.

Published
2021

33. Different modalities of measuring life engagement in people living with schizophrenia spectrum disorders: A preliminary analysis.

Author

Cerati, C., Calzavara-Pinton, I., Nibbio, G., Cicale, A., Zardini, D., Italia, M., Altieri, L., Lisoni, J., Deste, G., Barlati, S., and Vita, A.

Subjects
SCHIZOPHRENIA, MEDICAL personnel, PSYCHOSOCIAL functioning, MENTAL health personnel, WELL-being
Abstract

Introduction: The concept of "life engagement" encompasses several aspects of one's life, including personal well-being, contentment, purpose, and engagement in meaningful activities. In 2006, the group led by Scheier designed a 6-item scale to measure this concept in the general population: the Life Engagement Test (LET), however, this tool was never validated in clinical populations (Scheier et al. 2006 J Clin Psychiatry 2006; 29 291-298). In subjects living with schizophrenia life engagement can be measured through the Positive and Negative Syndrome Scale-Life Engagement (PANSS-LE), derived by isolating 11 items (i.e., N01, N02, N03, N04, N05, N06, G06, G07, G13, G15, G16) from the PANSS (Correll et al. 2022 J Clin Psychiatry 2022; 83-4) (Correll et al. 2022 J Clin Psychiatry 2022; 83-5). Objectives: The aim of this study was to investigate the clinical and functional correlates of two different measures of life engagement in a cohort of individuals living with schizophrenia spectrum disorders (SSD). Methods: Ninety-five subjects living with SSD recruited from the ASST Spedali Civili of Brescia (Italy) were included in the preliminary ad-interim analysis of the present study: for each patient information regarding the clinical presentation were measured with the Clinical Global Impression (CGI) scale, the Health of the Nation Outcome Scales (HoNOS), the Brief Negative Symptoms Scale (BNSS) and the PANSS; additionally, information related to the psychosocial functioning were collected through the Global Assessment of Functioning (GAF) scale; finally, life engagement was evaluated through the LET and the PANSS-LE. Spearman's correlations were performed using SPSS v28 and p values < 0.05 were considered significant. Results: Both the LET and the PANSS-LE were correlated with the CGI (p=0.002 and p<0.001 respectively), but only the PANSS-LE was found to be correlated with the GAF (p<0.001), the BNSS (p<0.001) and the HoNOS (p<0.001). Conclusions: The concept of life engagement is of growing interest for healthcare professionals working in the mental health field, in line with the concept of reaching a full functional recovery and considering patient-reported outcomes. From our study it is evident that life engagement in individuals living with SSD is better characterized through the PANSS-LE rather than the LET, as the former is more specific to define the complexity of the SSD symptomatology. Disclosure of Interest: None Declared [ABSTRACT FROM AUTHOR]

Published
2024
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34. Are direct costs in schizophrenia influenced by duration of illness? results from a restrospective follow-up study.

Author

Calzavara-Pinton, I., Nibbio, G., Cabassi, B., Invernizzi, E., Di Carlo, D., Necchini, N., Bertoni, L., Lisoni, J., Deste, G., Barlati, S., and Vita, A.

Subjects
COMMUNITY mental health services, MEDICAL care costs, SCHIZOPHRENIA, OUTPATIENT medical care, MEDICAL rehabilitation
Abstract

Introduction: In Italy, it was recently estimated that the total economic burden for schizophrenia is € 2.7 billions, of which around 50% is derived from direct costs and 81% of these are due to hospitalization, residential facilities and semi-residential facilities, whereas only 10% of direct costs is derived from pharmacotherapy (Marcellusi et al. BMJ Open 2018; 8, e018359). Considered the high economic burden that schizophrenia has on healthcare systems (estimated to be between 1.4 % and 3 % of the total), a better characterization of the clinical variables that mostly influence the costs represent a topic of great clinical interest (Altamura et al. 2014 Official Journal of the Italian Society of Psychopathology 2014; 20, 223–243). Objectives: The aim of this study was to analyze whether duration of illness has an impact on the costs derived from the use of services (which account for the majority of the direct costs) in a cohort of subjects living with schizophrenia spectrum disorders (SSD). Methods: A total of 496 subjects receiving treatment from the Community Mental Health Centers (CMHC) of Brescia (Italy) were included in the study: for each patient demographic data, data regarding the duration of illness (in months), and data related to the use of service between January 1st, 2022 and December 31st, 2022 were derived from the regional database of mental health ("SIPRL"). Data on the use of service were then converted to costs using the regional rate tables for outpatient services, residential and semi-residential facilities, and the Diagnosis-Related Groups (DRG)-driven rate tables for hospitalization data. Partial correlations analyses were performed between duration of illness, corrected for age, and cost-related variables. All analyses were performed through SPSS v28 and p values <0.05 were considered significant. Results: A higher duration of illness was correlated with higher costs for outpatient non-pharmacological interventions (p=0.010), for residential facilities (p=0.025) and total costs, both including and excluding hospital admissions (p=0.005 and p=0.007, respectively), but not with hospitalization costs (p=0.773). Conclusions: The total expenditure for people living with SSD is higher for people with a longer duration of illness. These findings raise an important issue, which is that the mental health system in Italy invests more in subjects with a longer history of disease: this is in contrast with the international guidelines which prompt to intervene early in the course of the disease in patients living with SSD with outpatient rehabilitation interventions. Disclosure of Interest: None Declared [ABSTRACT FROM AUTHOR]

Published
2024
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36. The association between insight and depressive symptoms in schizophrenia: Undirected and Bayesian network analyses

Author

Amore, M., Murri, M. B., Calcagno, P., Rocca, P., Rossi, A., Aguglia, E., Bellomo, A., Blasi, G., Carpiniello, B., Cuomo, A., Dell'Osso, L., Di Giannantonio, M., Giordano, G. M., Marchesi, C., Monteleone, P., Montemagni, C., Oldani, L., Pompili, M., Roncone, R., Rossi, R., Siracusano, A., Vita, A., Zeppegno, P., Corso, A., Arzani, C., Galderisi, S., Maj, M., Petrilli, G., Respino, M., Papalino, M., Falsetti, A., Calia, V. M., Barlati, S., Deste, G., Turrina, C., Pinna, F., Lai, A., Di Santa Sofia, S. L., Signorelli, M. S., Petralia, A., Pettorruso, M., Barone, G., Salone, A., Piegari, G., Aiello, C., Brando, F., Giuliani, L., Altamura, M., Carnevale, R., Padalino, F., Giusti, L., Salza, A., Ussorio, D., Pizziconi, G., Santarelli, V., Pacitti, F., De Bartolomeis, A., Gambaro, E., Gattoni, E., Gramaglia, C., De Panfilis, C., Ossola, P., Tonna, M., Carmassi, C., Carpita, B., Cremone, I., Comparelli, A., Corigliano, V., Brugnoli, R., Corrivetti, G., Cascino, G., Del Buono, G., Fagiolini, A., Bolognesi, S., Goracci, A., Di Lorenzo, G., Niolu, C., Ribolsi, M., Bellino, S., Bozzatello, P., Brasso, C., Amore, M., Murri, M. B., Calcagno, P., Rocca, P., Rossi, A., Aguglia, E., Bellomo, A., Blasi, G., Carpiniello, B., Cuomo, A., Dell'Osso, L., di Giannantonio, M., Giordano, G. M., Marchesi, C., Monteleone, P., Montemagni, C., Oldani, L., Pompili, M., Roncone, R., Rossi, R., Siracusano, A., Vita, A., Zeppegno, P., Corso, A., Arzani, C., Galderisi, S., and Maj, M.

Subjects
Adult, Male, media_common.quotation_subject, Social Stigma, Hostility, NO, Suicidal Ideation, Extrapyramidal symptoms, Demoralization, depression, insight, sadness, schizophrenia, self-esteem, Sadness, Self-esteem, medicine, Humans, Suicidal ideation, media_common, Depression, Insight, Schizophrenia, Bayes Theorem, Cross-Sectional Studies, Diagnostic and Statistical Manual of Mental Disorders, Female, Middle Aged, Self Concept, Social Class, Guilt, Schizophrenic Psychology, Positive and Negative Syndrome Scale, Sadne, medicine.disease, Psychiatry and Mental health, Settore MED/25, medicine.symptom, Psychology, Neurocognitive, Research Article, Clinical psychology, Diagnosis of schizophrenia
Abstract

Background. Greater levels of insight may be linked with depressive symptoms among patients with schizophrenia, however, it would be useful to characterize this association at symptom-level, in order to inform research on interventions. Methods. Data on depressive symptoms (Calgary Depression Scale for Schizophrenia) and insight (G12 item from the Positive and Negative Syndrome Scale) were obtained from 921 community-dwelling, clinically-stable individuals with a DSM-IV diagnosis of schizophrenia, recruited in a nationwide multicenter study. Network analysis was used to explore the most relevant connections between insight and depressive symptoms, including potential confounders in the model (neurocognitive and social-cognitive functioning, positive, negative and disorganization symptoms, extrapyramidal symptoms, hostility, internalized stigma, and perceived discrimination). Bayesian network analysis was used to estimate a directed acyclic graph (DAG) while investigating the most likely direction of the putative causal association between insight and depression. Results. After adjusting for confounders, better levels of insight were associated with greater self-depreciation, pathological guilt, morning depression and suicidal ideation. No difference in global network structure was detected for socioeconomic status, service engagement or illness severity. The DAG confirmed the presence of an association between greater insight and self-depreciation, suggesting the more probable causal direction was from insight to depressive symptoms. Conclusions. In schizophrenia, better levels of insight may cause self-depreciation and, possibly, other depressive symptoms. Person-centered and narrative psychotherapeutic approaches may be particularly fit to improve patient insight without dampening self-esteem., Highlights Better insight seems associated with depressive symptoms in schizophrenia.Network analyses were used to explore this association in a large sample.Insight was associated with self-depreciation, guilt, and suicidal ideation.Although cross-sectional, data suggest causal direction from insight to depression.

Published
2020

38. Familial aggregation of MATRICS Consensus Cognitive Battery scores in a large sample o outpatients with schizophrenia and their unaffected relatives

Author

Mucci A., Galderisi S., Green M. F., Nuechterlein K., Rucci P., Gibertoni D., Rossi A., Rocca P., Bertolino A., Bucci P., Hellemann G., Spisto M., Palumbo D., Aguglia E., Amodeo G., Amore M., Bellomo A., Brugnoli R., Carpiniello B., Dell'osso L., Di Fabio F., Di Giannantonio M., Di Lorenzo G., Marchesi C., Monteleone P., Montemagni C., Oldani L., Romano R., Roncone R., Stratta P., Tenconi E., Vita A., Zeppegno P., Maj M., Piegari G., Vignapiano A., Caputo F., Plescia G., Montefusco V., Mancini M., Attrotto M. T., Paladini V., Atti A. R., Barlati S., Galluzzo A., Mussoni C., Pinna F., Sanna L., Primavera D., Signorelli M. S., Minutolo G., Cannavo D., Acciavatti T., Santacroce R., Corbo M., Altamura M., La Montagna M., Carnevale R., Pizziconi G., Rossi R., Santarelli V., Giusti L., Malavolta M., Salza A., Murri M. B., Calcagno P., Bugliani M., Serati M., Orsenigo G., Gramaglia C., Gattoni E., Cattaneo C., Campagnola N., Ferronato L., Piovan C., Tonna M., Bettini E., Ossola P., Gesi C., Landi P., Rutigliano G., Biondi M., Girardi P., Buzzanca A., Zocconali M., Comparelli A., Mancinelli I., Niolu C., Ribolsi M., Siracusano A., Corrivetti G., Bartoli L., Diasco F., Bolognesi S., Goracci A., Fagiolini A., Bellino S., Cardillo S., Bracale N., Mucci, A., Galderisi, S., Green, M. F., Nuechterlein, K., Rucci, P., Gibertoni, D., Rossi, A., Rocca, P., Bertolino, A., Bucci, P., Hellemann, G., Spisto, M., Palumbo, D., Aguglia, E., Amodeo, G., Amore, M., Bellomo, A., Brugnoli, R., Carpiniello, B., Dell'Osso, L., Di Fabio, F., Di Giannantonio, M., Di Lorenzo, G., Marchesi, C., Monteleone, P., Montemagni, C., Oldani, L., Romano, R., Roncone, R., Stratta, P., Tenconi, E., Vita, A., Zeppegno, P., Maj, M., Piegari, G., Vignapiano, A., Caputo, F., Plescia, G., Montefusco, V., Mancini, M., Attrotto, M. T., Paladini, V., Atti, A. R., Barlati, S., Galluzzo, A., Mussoni, C., Pinna, F., Sanna, L., Primavera, D., Signorelli, M. S., Minutolo, G., Cannavo, D., Acciavatti, T., Santacroce, R., Corbo, M., Altamura, M., La Montagna, M., Carnevale, R., Pizziconi, G., Rossi, R., Santarelli, V., Giusti, L., Malavolta, M., Salza, A., Murri, M. B., Calcagno, P., Bugliani, M., Serati, M., Orsenigo, G., Gramaglia, C., Gattoni, E., Cattaneo, C., Campagnola, N., Ferronato, L., Piovan, C., Tonna, M., Bettini, E., Ossola, P., Gesi, C., Landi, P., Rutigliano, G., Biondi, M., Girardi, P., Buzzanca, A., Zocconali, M., Comparelli, A., Mancinelli, I., Niolu, C., Ribolsi, M., Siracusano, A., Corrivetti, G., Bartoli, L., Diasco, F., Bolognesi, S., Goracci, A., Fagiolini, A., Bellino, S., Cardillo, S., Bracale, N., and di Giannantonio, M.

Subjects
Attention, MCCB Italian standardization, reasoning and problem solving, social cognition, verbal learning, working memory, Proband, Adult, Male, Consensus, Psychometrics, Context (language use), social cognition, Verbal learning, working memory, 03 medical and health sciences, Attention, MCCB Italian standardization, reasoning and problem solving, verbal learning, Aged, Cognition, Cognitive Dysfunction, Family, Female, Humans, Middle Aged, Outpatients, Psychiatric Status Rating Scales, Schizophrenia, Schizophrenic Psychology, 0302 clinical medicine, Social cognition, medicine, Applied Psychology, Psychiatry and Mental Health, Family aggregation, medicine.disease, 030227 psychiatry, Settore MED/25, Psychology, MATRICS, Neurocognitive, 030217 neurology & neurosurgery, Clinical psychology
Abstract

BackgroundThe increased use of the MATRICS Consensus Cognitive Battery (MCCB) to investigate cognitive dysfunctions in schizophrenia fostered interest in its sensitivity in the context of family studies. As various measures of the same cognitive domains may have different power to distinguish between unaffected relatives of patients and controls, the relative sensitivity of MCCB tests for relative–control differences has to be established. We compared MCCB scores of 852 outpatients with schizophrenia (SCZ) with those of 342 unaffected relatives (REL) and a normative Italian sample of 774 healthy subjects (HCS). We examined familial aggregation of cognitive impairment by investigating within-family prediction of MCCB scores based on probands’ scores.MethodsMultivariate analysis of variance was used to analyze group differences in adjusted MCCB scores. Weighted least-squares analysis was used to investigate whether probands’ MCCB scores predicted REL neurocognitive performance.ResultsSCZ were significantly impaired on all MCCB domains. REL had intermediate scores between SCZ and HCS, showing a similar pattern of impairment, except for social cognition. Proband's scores significantly predicted REL MCCB scores on all domains except for visual learning.ConclusionsIn a large sample of stable patients with schizophrenia, living in the community, and in their unaffected relatives, MCCB demonstrated sensitivity to cognitive deficits in both groups. Our findings of significant within-family prediction of MCCB scores might reflect disease-related genetic or environmental factors.

Published
2018

39. The complex relationship between self-reported 'personal recovery' and clinical recovery in schizophrenia

Author

Rossi, A, Amore, M, Galderisi, S, Rocca, P, Bertolino, A, Aguglia, E, Amodeo, G, Bellomo, A, Bucci, P, Buzzanca, A, Carpiniello, B, Comparelli, A, Dell'Osso, L, Giannantonio, M, Mancini, M, Marchesi, C, Monteleone, P, Montemagni, C, Oldani, L, Roncone, R, Siracusano, A, Stratta, P, Tenconi, E, Vignapiano, A, Vita, A, Zeppegno, P, Maj, M, Rossetti, M, Rossi, R, Santarelli, V, Giusti, L, Malavolta, M, Salza, A, Palumbo, D, Patriarca, S, Chieffi, M, Attrotto, M, Colagiorgio, L, Andriola, I, Atti, A, Barlati, S, Deste, G, Galluzzo, A, Pinna, F, Deriu, L., Sanna, L, Signorelli, M., Minutolo, G, Cannavò, D, Martinotti, G, Acciavatti, T, Corbo, M, Altamura, M, Carnevale, R, Malerba, S, Murri, M, Calcagno, P, Bugliani, M, Serati, M, Bartolomeis, A, Gramaglia, C, Gattoni, E, Gambaro, E, Collantoni, E, Cremonese, C, Rossi, E, Ossola, P, Tonna, M, Panfilis, C, Rutigliano, G, Gesi, C, Carmassi, C, Biondi, M, Girardi, P, Brugnoli, R, Fabio, F, Pietro, S, Girardi, N, Niolu, C, Lorenzo, G, Ribolsi, M, Corrivetti, G, Pinto, G, Longobardi, N, Fagiolini, A, Goracci, A, Bolognesi, S, Bellino, S, Villari, V, Bracale, N, Rossi, A., Amore, M., Galderisi, S., Rocca, P., Bertolino, A., Aguglia, E., Amodeo, G., Bellomo, A., Bucci, P., Buzzanca, A., Carpiniello, B., Comparelli, A., Dell'Osso, L., Giannantonio, M. D., Mancini, M., Marchesi, C., Monteleone, P., Montemagni, C., Oldani, L., Roncone, R., Siracusano, A., Stratta, P., Tenconi, E., Vignapiano, A., Vita, A., Zeppegno, P., Maj, M., Rossetti, M. C., Rossi, R., Santarelli, V., Giusti, L., Malavolta, M., Salza, A., Palumbo, D., Patriarca, S., Chieffi, M., Attrotto, M. T., Colagiorgio, L., Andriola, I., Atti, A. R., Barlati, S., Deste, G., Galluzzo, A., Pinna, F., Deriu, L., Sanna, L., Signorelli, M. S., Minutolo, G., Cannavo, D., Martinotti, G., Acciavatti, T., Corbo, M., Altamura, M., Carnevale, R., Malerba, S., Murri, M. B., Calcagno, P., Bugliani, M., Serati, M., Bartolomeis, A., Gramaglia, C., Gattoni, E., Gambaro, E., Collantoni, E., Cremonese, C., Rossi, E., Ossola, P., Tonna, M., Panfilis, C. D., Rutigliano, G., Gesi, C., Carmassi, C., Biondi, M., Girardi, P., Brugnoli, R., Fabio, F. D., Pietro, S. D., Girardi, N., Niolu, C., Lorenzo, G. D., Ribolsi, M., Corrivetti, G., Pinto, G., Longobardi, N., Fagiolini, A., Goracci, A., Bolognesi, S., Bellino, S., Villari, V., and Bracale, N.

Subjects
Adult, Male, Schizophrenia, Personal recovery, Clinical recovery, Insight, Recovery styles, Cluster analysis, Clinical recovery, Coping (psychology), Cross-sectional study, Recovery style, 03 medical and health sciences, Diagnostic Self Evaluation, 0302 clinical medicine, Cluster analysis, Recovery styles, Insight, Personal recovery, Schizophrenia, Cluster Analysis, Cross-Sectional Studies, Female, Humans, Psychiatric Status Rating Scales, Self Report, Recovery of Function, Schizophrenic Psychology, Cluster analysi, Self report, Settore MED/25 - Psichiatria, Biological Psychiatry, 030227 psychiatry, Psychiatry and Mental Health, Psychiatric status rating scales, Biological psychiatry, Psychology, 030217 neurology & neurosurgery, Clinical psychology
Abstract

Self-reported 'personal recovery' and clinical recovery in schizophrenia (SRPR and CR. respectively) reflect different perspectives in schizophrenia outcome, not necessarily concordant with each other and usually representing the consumer's or the therapist's point of view. By means of a cluster analysis on SRPR related variables, we identified three dusters. The first and third cluster included subjects with the best and the poorest clinical outcome respectively. The second cluster was characterized by better insight, higher levels of depression and stigma, lowest self-esteem and personal strength, and highest emotional coping. The first duster showed positive features of recovery, while the third duster showed negative features. The second cluster, with the most positive insight, showed a more complex pattern, a some-what 'paradoxical' mixture of positive and negative personal and clinical features of recovery. The present results suggest the need for a characterization of persons with schizophrenia along SRPR and CR dimensions to design individualized and integrated treatment programs aimed to improve insight and coping strategies, reduce stigma and shape recovery styles. (C) 2017 Elsevier B.V. All rights reserved.

Published
2018

44. Neurobiological and clinical effect of metacognitive interpersonal therapy vs structured clinical model: study protocol for a randomized controlled trial

Author

Magni, LAURA ROSA, Carcione, Antonino, Ferrari, Clarissa, Semerari, Antonio, Riccardi, Ilaria, Nicolo', Giuseppe, Lanfredi, Mariangela, Pedrini, Laura, Cotelli, Maria, Bocchio, Luisella, Pievani, Michela, Gasparotti, Roberto, Rossi, Roberta, Rossi, R, Magni, Lr, Lanfredi, M, Pedrini, L, Carcione, A, Semerari, A, Riccardi, I, Nicolo', G, Almici, M, Beneduce, R, Borsci, G, Caprioli, C, Nodari, M, Vita, A, Barlati, S, Laffranchini, L, Rillosi, L, Rossi, G, Bocchio, L, Cattaneo, A, Cattane, N, Tura, Gb, Bignotti, S, Speziali, M, Cotelli, M, Rosini, S, Gasparotti, R, Ambrosi, C, Mascaro, L, Corbo, D, Pievani, M, Quattrini, G, Bilotta, E, Colle, L, Conti, L, Fiore, D, Micheloni, A, Procacci, M, and Silvestre, V.

Subjects
Adult, Male, Adolescent, lcsh:RC435-571, Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, medicine.medical_treatment, Neuroimaging, Impulsivity, law.invention, Study Protocol, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Alexithymia, law, Emotionality, lcsh:Psychiatry, mental disorders, medicine, Humans, 030212 general & internal medicine, Borderline personality disorder, Interpersonal Psychotherapy, Emotion dysregulation, Metacognition, Psychotherapy, business.industry, Borderline Personality Disorder, Female, Middle Aged, Treatment Outcome, medicine.disease, 030227 psychiatry, Clinical trial, Cognitive behavioral therapy, Psychiatry and Mental health, Adjunctive treatment, medicine.symptom, business, Clinical psychology
Abstract

Background Borderline Personality Disorder (BPD) is a complex and debilitating disorder, characterized by deficits in metacognition and emotion dysregulation. The “gold standard” treatment for this disorder is psychotherapy with pharmacotherapy as an adjunctive treatment to target state symptoms. The present randomized clinical trial aims to assess the clinical and neurobiological changes following Metacognitive Interpersonal Therapy (MIT) compared with Structured Clinical Management (SCM) derived from specific recommendations in APA (American Psychiatric Association) guidelines for BPD. Methods The study design is a randomized parallel controlled clinical trial and will include 80 BPD outpatients, aged 18–45 enrolled at 2 recruitment centers. Primary outcome will be the clinical change in emotion regulation capacities assessed with the Difficulties in Emotion Regulation Scale (DERS). We will also investigated the effect of psychotherapy on metacognitive abilities and several clinical features such as BPD symptomatology, general psychopathology, depression, personal functioning, and trait dimensions (anger, impulsivity, alexithymia). We will evaluate changes in brain connectivity patterns and during the view of emotional pictures. A multidimensional assessment will be performed at the baseline, at 6, 12, 18 months. We will obtain structural and functional Magnetic Resonance Images (MRIs) in MIT-Treated BPD (N = 30) and SCM-treated BPD (N = 30) at baseline and after treatment, as well as in a group of 30 healthy and unrelated volunteers that will be scanned once for comparison. Discussion The present study could contribute to elucidate the neurobiological mechanisms underlying psychotherapy efficacy. The inclusion of a multidisciplinary study protocol will allow to study BPD considering different features that can affect the treatment response and their reciprocal relationships. Trial registration NCT02370316. Registered 02/24/2015. Electronic supplementary material The online version of this article (10.1186/s12888-019-2127-2) contains supplementary material, which is available to authorized users.

Published
2019
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45. Identification of symbol digit modality test score extremes in Huntington's disease

Author

Braisch, U, Muche, R, Rothenbacher, D, Landwehrmeyer, GB, Long, JD, Bentivoglio, AR, Biunno, I, Bonelli, RM, Dunnett, SB, Illmann, T, Levey, J, Ramos-Arroyo, M, Nielsen, JE, Paivarinta, M, Sebastian, AR, Tabrizi, SJ, Vandenberghe, W, Uhrova, T, Come, A, Garde, MB, Betz, S, Capodarca, S, Wildson, SC, da Silva, V, Di Renzo, M, Finisterra, M, Genoves, C, Gilling, M, Handley, OJ, Hvalstedt, C, Koppers, K, Lamanna, C, Laura, M, Descals, AM, Monza, D, Mutze, L, Oehmen, M, Padieu, H, Paterski, L, Koivisto, SP, Rindal, B, Roren, N, Sasinkova, P, Seliverstov, Y, Timewell, E, Cubillo, PT, van Walsem, MR, Witjes-Ane, MN, Yudina, E, Zielonka, E, Zinzi, P, Braunwarth, EM, Brugger, F, Buratti, L, Hametner, EM, Hepperger, C, Holas, C, Hotter, A, Hussl, A, Larcher, B, Mahlknecht, P, Muller, C, Pinter, B, Poewe, W, Seppi, K, Sprenger, F, Wenning, G, Dupuis, M, Minet, C, Ribai, P, Van Paemel, D, Verellen-Dumoulin, C, Klempir, J, Majerova, V, Roth, J, Babiloni, B, Debruxelles, S, Duche, C, Goizet, C, Jameau, L, Lafoucriere, D, Spampinato, U, Bachoud-Levi, AC, Boisse, MF, de Langavant, LC, Lemoine, L, Morgado, G, Youssov, K, Annic, A, Barthelemy, R, De Bruycker, C, Cabaret, M, Carette, AS, Carriere, N, Decorte, E, Defebvre, L, Delliaux, M, Delval, A, Depelchin, A, Destee, A, Dewulf-Pasz, N, Dondaine, T, Dugauquier, F, Dujardin, K, Lemaire, MH, Manouvrier, S, Peter, M, Plomhause, L, Sablonniere, B, Simonin, C, Tard, C, Thibault-Tanchou, S, Vuillaume, I, Bellonet, M, Benoit, A, Blin, S, Courtin, F, Duru, C, Fasquel, V, Godefroy, O, Krystkowiak, P, Mantaux, B, Roussel, M, Tir, M, Schuler, B, Wannepain, S, Azulay, JP, Chabot, C, Delfini, M, Eusebio, A, Fluchere, F, Grosjean, H, Mundler, L, Nowak, M, Bioux, S, Bliaux, E, Girard, C, Guyant-Marechal, L, Hannequin, D, Hannier, V, Jourdain, S, Maltete, D, Pouliquen, D, Blondeau, L, Calvas, F, Cheriet, S, Delabaere, H, Demonet, JF, Pariente, J, Pierre, M, Beuth, M, Gelderblom, H, Priller, J, Pruss, H, Spruth, E, Thiel, S, Ellrichmannberlin, G, Herrmann, L, Hoffmann, R, Kaminski, B, Saft, C, Bosredon, C, Hunger, U, Lohle, M, Maass, A, Ossig, C, Schmidt, S, Storch, A, Wolz, A, Wolz, M, Kohl, Z, Kozay, C, Ullah, J, Winkler, J, Bergmann, U, Boringer, R, Capetian, P, Kammel, G, Lambeck, J, Meier, S, Rijntjes, M, Zucker, B, Boelmans, K, Ganos, C, Goerendt, I, Heinicke, W, Hidding, U, Munchau, A, Schmalfeld, J, Stubbe, L, Zittel, S, Diercks, G, Dressler, D, Francis, F, Gayde-Stephan, S, Gorzolla, H, Kramer, B, Minschke, R, Schrader, C, Tacik, P, Longinus, B, Lusebrink, A, Muhlau, M, Peinemann, A, Stadtler, M, Weindl, A, Winkelmann, J, Ziegler, C, Bechtel, N, Beckmann, H, Bohlen, S, Gopfert, N, Holzner, E, Lange, H, Reilmann, R, Rohm, S, Rumpf, S, Sass, C, Schepers, S, Weber, N, Barth, K, Buck, A, Connemann, J, Ecker, D, Geitner, C, Held, C, Kesse, A, Landwehrmeyer, B, Lezius, F, Lewerenz, J, Nepper, S, Niess, A, Orth, M, Schneider, A, Schwenk, D, Sussmuth, S, Trautmann, S, Weydt, P, Klebe, S, Musacchio, T, Leypold, C, Noth, K, Cormio, C, de Tommaso, M, Franco, G, Sciruicchio, V, Serpino, C, Calandra-Buonaura, G, Capellari, S, Cortelli, P, Gallassi, R, Poda, R, Sambati, L, Scaglione, C, Maserati, MS, Agosti, C, Barlati, S, Compostella, S, Marchina, E, Padovani, A, Bertini, E, Ghelli, E, Ginestroni, A, Mechi, C, Paganini, M, Piacentini, S, Pradella, S, Romoli, AM, Sorbi, S, Abbruzzese, G, di Poggio, MB, Ferrandes, G, Mandich, P, Marchese, R, Tamburini, T, Baake, V, van den Bogaard, SJA, Bos, R, Dumas, EM, t'Hart, EP, Kampstra, A, Roos, RAC, Schoonderbeek, A, Aaserud, O, Bjorgo, K, Borgeod, N, Dramstad, E, Fannemel, M, Frich, JC, Gorvell, PF, Heiberg, A, Lorentzen, E, Retterstol, L, Rosby, O, Sikiric, A, Stokke, B, van Walsem, M, Wehus, R, Bjornevoll, I, Sando, SB, Haug, MG, Storseth, HH, Arntsen, V, Dziadkiewicz, A, Konkel, A, Narozanska, E, Robowski, P, Sitek, E, Slawek, J, Soltan, W, Szinwelski, M, Arkuszewski, M, Blaszczyk, M, Boczarska-Jedynak, M, Ciach-Wysocka, E, Gorzkowska, A, Nska-Myga, BJ, Kaczmarczyk, A, Klodowska-Duda, G, Opala, G, Stompel, D, Banaszkiewicz, K, Bocwinska, D, Bojakowska-Jaremek, K, Dec, M, Grabska, N, Krawczyk, GM, Kubowicz, E, Malec-Litwinowicz, M, Rudzinska, M, Stenwak, A, Szczudlik, A, Szczygiel, E, Wojcik, M, Wasielewska, A, Bryl, JAA, Ciesielska, A, Klimberg, A, Marcinkowski, J, Samara, H, Sempolowicz, J, Sniewski, BW, Zielonka, D, Gogol, A, Janik, P, Jamrozik, Z, Kaminska, A, Kwiecinski, H, Antczak, J, Jachinska, K, Krysa, W, Rakowicz, M, Richter, P, Rola, R, Ryglewicz, D, Sienkiewicz-Jarosz, H, Stepniak, I, Sulek, A, Witkowski, G, Zaremba, J, Zdzienicka, E, Ziora-Jakutowicz, K, Januario, C, Julio, F, Guedes, LC, Coelho, M, Finisterra, AM, Ferreira, JJ, Mestre, T, Mendes, T, Rosa, MM, Valadas, A, Kopishinskaya, S, Korotysh, M, Herrera, CD, Moreno, PG, Bas, J, Busquets, N, Calopa, M, Classen, SJ, Dedicha, NR, Buongiorno, MT, Maria, ADS, Munoz, E, Santacruz, P, Barbera, MA, Pardo, SA, Guia, DB, Calzado, N, Hernanz, LC, Diaz-Zorita, JPT, Catena, JL, Ferrer, PQ, Carruesco, GT, Robert, MF, Viladrich, CM, Roca, E, Idiago, JMR, Riballo, AV, Campolongo, A, de Bobadilla, RF, Bojarsky, JK, Martinez-Horta, S, Pagonabarraga, J, Perez, JP, Ribosa, R, Villa, C, Gil, MAA, Corrales, KB, Esteban, JCG, Gonzalez, A, Merino, BT, Cubo, E, Polo, CG, Mariscal, N, Romero, SG, Arbelo, JM, de Molina, RM, Martin, I, Perianez, JM, Udaeta, B, Alonso-Frech, F, Frades, B, Villanueva, MA, Sevilla, MAZ, Frech, FA, Fenollar, MD, Garcia, RGR, Villanueva, C, Bascunana, M, Ventura, MF, Ribas, GG, de Yebenes, JG, Moreno, JLLS, Barral, VM, Ruiz, PJG, Garcia, A, Lopez, RG, Barcenas, AH, Martinez-Descals, A, Martin, VP, Martinez, NR, Artiga, MJS, Sanchez, V, Pueyo, A, Gonzalez, S, Guisasola, LM, Ribacoba, MPPR, Salvador, C, Lozano, PS, Caldentey, JG, Ramirez, IL, Arques, PN, Lopera, MR, Pastor, BV, Gaston, I, Garcia-Amigot, F, Martinez-Jaurrieta, MD, Ramos-Arroyo, MA, Carrillo, F, Redondo, MTC, Mir, P, Gonzalez, LV, Moreno, JMG, Lucena, CM, Pena, JC, Redondo, L, Sanchez, VS, Fernandez, CM, Mata, MP, Lemos, MDR, Bosca, M, Burguera, JA, Vilaplana, FCBCP, Solis, P, Figuerola, BJ, Palanca, PM, Berglund, P, Constantinescu, R, Fredlund, G, Hosterey-Ugander, U, Linnsand, P, Neleborn-Lingefjard, L, Wahlstrom, J, Palhagen, S, Svenningsson, P, Paucar, M, Wallden, T, Ekwall, C, Goller, ML, Sundblom, J, Stebler, Y, Kaelin, A, Romero, I, Schupbach, M, Zaugg, SW, Jung, H, Petersen, J, Auer, M, Mihaylova, V, Vernon, N, Akhtar, S, Crooks, J, Curtis, A, de Souza, J, Piedad, J, Rickards, H, Wright, J, Pallett, A, Coulthard, E, Gethin, L, Hayward, B, Sieradzan, K, Wright, A, Busse, M, Butcher, C, Dunnett, S, Clenaghan, C, Hunt, S, Jones, L, Jones, U, Khalil, H, Minster, S, Owen, M, Price, K, Townhill, J, Rosser, A, Edwards, M, Ho, C, McGill, M, Porteous, M, Pearson, P, Harrower, T, Irvine, S, Brockie, P, Foster, J, Johns, N, McKenzie, S, Rothery, J, Thomas, G, Yates, S, Deith, C, Ireland, J, Ritchie, S, Andrew, A, Frost, J, Noad, R, Cosgrove, J, Gallantree, D, Hamer, S, Hobson, E, Jamieson, S, Kraus, A, Longthorpe, M, Markova, I, Musgrave, H, Peacy, C, Raman, A, Rowett, L, Toscano, J, Wild, S, Yardumian, P, Clayton, C, Dipple, H, Freire-Patino, D, Hallam, C, Middleton, J, Alusi, S, Davies, R, Foy, K, Gerrans, E, Leggett, H, Pate, L, Anjum, U, Coebergh, J, Eddy, C, McEntagart, M, Patton, M, Peterson, M, Rose, S, Andrews, T, Brown, S, Bruno, S, Doherty, K, Golding, C, Haider, S, Hensman, D, Lahiri, N, Lewis, M, Novak, M, Patel, A, Robertson, N, Rosser, E, Tabrizi, S, Taylor, R, Warner, T, Wild, E, Arran, N, Bek, J, Callaghan, J, Craufurd, D, Fullam, R, Howard, L, Huson, S, Johnson, L, Jones, M, Krishnamoorthy, A, Murphy, H, Oughton, E, Partington-Jones, L, Rogers, D, Sollom, A, Snowden, J, Stopford, C, Thompson, J, Tinkler, P, Trender-Gerhard, I, Verstraelen, N, Westmoreland, L, Cass, G, Davidson, L, Davison, J, Fullerton, N, Holmes, K, Komati, S, McDonnell, S, Mohammed, Z, Morgan, K, Savage, L, Singh, B, Wood, J, Chu, E, Knight, C, O'Neill, M, Das Purkayastha, D, Nemeth, AH, Siuda, G, Valentine, R, Dixon, K, Armstrong, R, Harrison, D, Hughes, M, Large, S, Donovan, JO, Palmer, A, Parkinson, A, Soltysiak, B, Timings, L, Williams, J, Burn, J, Weekes, R, Craven, J, Bailey, W, Coleman, C, Haig-Brown, D, Simpson, S, Hare, M, Majeed, T, Bandmann, O, Bradbury, A, Fairtlough, H, Fillingham, K, Foustanos, I, Gill, P, Kazoka, M, Nevitt, L, Peppa, N, Quarrell, O, Taylor, C, Tidswell, K, O'Donovan, K, Agarwal, V, Anderson, M, Gunner, K, Harris, K, Hayward, E, Heywood, M, Keys, L, Kipps, C, MacKinnon, L, Smalley, S, Gowers, L, Powell, K, Bethwaite, P, Edwards, R, Fuller, K, Phillips, M, Tan, L, Burgunder, JM, Lau, PN, Pica, E, Shoulson, I, Gusella, JG, Antonijevic, I, vankammen, D, Foroud, T, Warner, J, Giuliano, J, Vetter, L, Marshall, F, Marder, K, Frucht, S, Moskowitz, C, Clouse, R, Wasserman, P, Shannon, K, Jaglin, J, Jankovic, J, Palao, A, Harrison, M, Singer, C, Quesada, M, Hersch, S, Rosas, D, Tanev, K, Malarick, K, Colcher, A, Sanchez-Ramos, J, Kostyk, S, Paulsen, J, Perlmutter, J, Tabbal, S, Ross, C, Dorsey, R, Nucifora, F, Dubinsky, R, Dubinsky, H, Suchowersky, O, Klimek, ML, Jones, R, Morgan, J, Mohlo, E, Kang, U, Agarwal, P, Factor, S, Jennings, D, Higgins, D, Adams, J, Frank, S, Saint-Hilaire, M, Diggin, M, Furtado, S, Walker, F, O'Neill, C, Quaid, K, LeDoux, M, Raymond, L, Leavitt, B, Decolongon, J, Perlman, S, Peavy, G, Goldstein, J, Kumar, R, McCusker, E, Griffith, J, Loy, C, Wheelock, V, Tempkin, T, Martin, A, Nance, M, Mallonee, W, Suter, G, Revilla, F, Gartner, M, Drazinic, C, Fitzpatrick, MJ, Panisset, M, Duff, K, Scott, B, Weiner, W, Robottom, B, Chiu, E, Yastrubetskaya, O, Churchyard, A, Greenamyre, TJ, Oakes, D, Beck, C, Robertson, S, Eaton, K, Lindsay, P, Deuel, L, MacDonald, M, Hickey, C, Muratori, L, Leserman, A, Doucette, N, Uc, E, Rodnitzky, R, Vik, S, Davis, R, Dietrich, S, Segro, V, Erickson, D, Hunt, V, Lucarelli, N, Broyles, J, Delarosa, J, Louis, E, Panegyres, P, Schmidt, A, Barton, S, Sperin, E, Testa, C, Thiede, F, Zauber, SE, McInnis, R, Welsh, C, Wesson, M, Coleman, A, and European Commission

Subjects
Adult, Male, congenital, hereditary, and neonatal diseases and abnormalities, COHORT, Cox hazard model, quantile regression, REGISTRY, symbol digit modalities test, Genotype, Neuropsychological Tests, Cohort Studies, 03 medical and health sciences, Cellular and Molecular Neuroscience, Cognition, 0302 clinical medicine, Huntington's disease, Rating scale, mental disorders, medicine, Humans, Verbal fluency test, Longitudinal Studies, Genetics (clinical), Proportional Hazards Models, 030304 developmental biology, 0303 health sciences, Proportional hazards model, business.industry, Reproducibility of Results, Middle Aged, medicine.disease, nervous system diseases, Psychiatry and Mental health, Huntington Disease, Phenotype, Test score, Cohort, Disease Progression, Female, Observational study, business, 030217 neurology & neurosurgery, Stroop effect, Clinical psychology
Abstract

REGISTRY Investigators of the European Huntington's Disease Network and COHORT Investigators of the Huntington Study Group., Studying individuals with extreme phenotypes could facilitate the understanding of disease modification by genetic or environmental factors. Our aim was to identify Huntington's disease (HD) patients with extreme symbol digit modality test (SDMT) scores. We first examined in HD the contribution of cognitive measures of the Unified Huntington's Disease Rating Scale (UHDRS) in predicting clinical endpoints. The language-independent SDMT was used to identify patients performing very well or very poorly relative to their CAG and age cohort. We used data from REGISTRY and COHORT observational study participants (5,603 HD participants with CAG repeats above 39 with 13,868 visits) and of 1,006 healthy volunteers (with 2,241 visits), included to identify natural aging and education effects on cognitive measures. Separate Cox proportional hazards models with CAG, age at study entry, education, sex, UHDRS total motor score and cognitive (SDMT, verbal fluency, Stroop tests) scores as covariates were used to predict clinical endpoints. Quantile regression for longitudinal language-independent SDMT data was used for boundary (2.5% and 97.5% quantiles) estimation and extreme score analyses stratified by age, education, and CAG repeat length. Ten percent of HD participants had an extreme SDMT phenotype for at least one visit. In contrast, only about 3% of participants were consistent SDMT extremes at two or more visits. The thresholds for the one-visit and two-visit extremes can be used to classify existing and new individuals. The identification of these phenotype extremes can be useful in the search for disease modifiers., This work was in part funded by a grant from the EuropeanCommission under the 7th framework programme (RD-Connect, grantagreement number 305444).

Published
2019
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49. Violence risk and mental disorders (VIORMED-2): A prospective multicenter study in Italy

Author

Barlati, S, Stefana, A, Bartoli, F, Bianconi, G, Bulgari, V, Candini, V, Carrà, G, Cavalera, C, Clerici, M, Cricelli, M, Ferla, M, Ferrari, C, Iozzino, L, Macis, A, Vita, A, de Girolamo, G, Barlati, Stefano, Stefana, Alberto, Bartoli, Francesco, Bianconi, Giorgio, Bulgari, Viola, Candini, Valentina, Carrà, Giuseppe, Cavalera, Cesare, Clerici, Massimo, Cricelli, Marta, Ferla, Maria Teresa, Ferrari, Clarissa, Iozzino, Laura, Macis, Ambra, Vita, Antonio, de Girolamo, Giovanni, Barlati, S, Stefana, A, Bartoli, F, Bianconi, G, Bulgari, V, Candini, V, Carrà, G, Cavalera, C, Clerici, M, Cricelli, M, Ferla, M, Ferrari, C, Iozzino, L, Macis, A, Vita, A, de Girolamo, G, Barlati, Stefano, Stefana, Alberto, Bartoli, Francesco, Bianconi, Giorgio, Bulgari, Viola, Candini, Valentina, Carrà, Giuseppe, Cavalera, Cesare, Clerici, Massimo, Cricelli, Marta, Ferla, Maria Teresa, Ferrari, Clarissa, Iozzino, Laura, Macis, Ambra, Vita, Antonio, and de Girolamo, Giovanni

Abstract

Background The management of mentally ill offenders in the community is one of the great challenges imposed on community psychiatry. Aim The aim of this study was to analyze the association between sociodemographic, clinical, and psychosocial factors and violent behavior in a sample of outpatients with severe mental disorders. Method This was a prospective cohort study with a baseline cross-sectional design used to provide a detailed analysis of patients’ profiles, followed by a longitudinal design to measure aggressive and violent behavior during a 1-year follow-up. Patients with severe mental disorders, with or without a history of violence, were enrolled in four Italian Departments of Mental Health and underwent a comprehensive multidimensional assessment. Results The sample included 247 outpatients, for a total of 126 cases and 121 controls. Compared to controls, patients with a history of violence had a greater frequency of lifetime domestic violence, a greater lifetime propensity to misuse substances, and a higher number of compulsory admissions. The forthnightly monitoring during the 1-year follow-up did show statistically significant differences in aggressive and violent behavior rates between the two groups. Verbal aggression was significantly associated with aggression against objects and physical aggression. Moreover, outpatients with an history of violence showed statistically significant higher MOAS scores compared to both residential patients with an history of violence, assessed in the first wave of this project, and all controls. Conclusions Patients with a history of violence had specific characteristics and showed a greater occurrence of additional community violence during a 1-year observation period. Our results may assist clinicians in implementing standardized methods of patient assessment and violence monitoring in outpatient mental health services and may prompt improved collaboration between different community services.

Published
2019

50. Neurobiological and clinical effect of metacognitive interpersonal therapy vs structured clinical model: study protocol for a randomized controlled trial

Author

Magni, L. R., Carcione, A., Ferrari, C., Semerari, A., Riccardi, I., Nicolo, G., Lanfredi, M., Pedrini, L., Cotelli, M., Bocchio, L., Pievani, M., Gasparotti, R., Rossi, R., Almici, M., Beneduce, R., Borsci, G., Caprioli, C., Nodari, M., Vita, A., Barlati, S., Laffranchini, L., Rillosi, L., Rossi, G., Cattaneo, A., Cattane, N., Tura, G. B., Bignotti, S., Speziali, M., Rosini, S., Ambrosi, C., Mascaro, L., Corbo, D., Quattrini, G., Bilotta, E., Colle, L., Conti, L., Fiore, D., Micheloni, A., Procacci, M., Silvestre, V., Cotelli M., Magni, L. R., Carcione, A., Ferrari, C., Semerari, A., Riccardi, I., Nicolo, G., Lanfredi, M., Pedrini, L., Cotelli, M., Bocchio, L., Pievani, M., Gasparotti, R., Rossi, R., Almici, M., Beneduce, R., Borsci, G., Caprioli, C., Nodari, M., Vita, A., Barlati, S., Laffranchini, L., Rillosi, L., Rossi, G., Cattaneo, A., Cattane, N., Tura, G. B., Bignotti, S., Speziali, M., Rosini, S., Ambrosi, C., Mascaro, L., Corbo, D., Quattrini, G., Bilotta, E., Colle, L., Conti, L., Fiore, D., Micheloni, A., Procacci, M., Silvestre, V., and Cotelli M.

Abstract

Background: Borderline Personality Disorder (BPD) is a complex and debilitating disorder, characterized by deficits in metacognition and emotion dysregulation. The "gold standard" treatment for this disorder is psychotherapy with pharmacotherapy as an adjunctive treatment to target state symptoms. The present randomized clinical trial aims to assess the clinical and neurobiological changes following Metacognitive Interpersonal Therapy (MIT) compared with Structured Clinical Management (SCM) derived from specific recommendations in APA (American Psychiatric Association) guidelines for BPD. Methods: The study design is a randomized parallel controlled clinical trial and will include 80 BPD outpatients, aged 18-45 enrolled at 2 recruitment centers. Primary outcome will be the clinical change in emotion regulation capacities assessed with the Difficulties in Emotion Regulation Scale (DERS). We will also investigated the effect of psychotherapy on metacognitive abilities and several clinical features such as BPD symptomatology, general psychopathology, depression, personal functioning, and trait dimensions (anger, impulsivity, alexithymia). We will evaluate changes in brain connectivity patterns and during the view of emotional pictures. A multidimensional assessment will be performed at the baseline, at 6, 12, 18 months. We will obtain structural and functional Magnetic Resonance Images (MRIs) in MIT-Treated BPD (N = 30) and SCM-treated BPD (N = 30) at baseline and after treatment, as well as in a group of 30 healthy and unrelated volunteers that will be scanned once for comparison. Discussion: The present study could contribute to elucidate the neurobiological mechanisms underlying psychotherapy efficacy. The inclusion of a multidisciplinary study protocol will allow to study BPD considering different features that can affect the treatment response and their reciprocal relationships. Trial registration: NCT02370316. Registered 02/24/2015.

Published
2019

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