Factors Influencing Social Functioning of People With Schizophrenia (PRIN2014)
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|ClinicalTrials.gov Identifier: NCT02166918|
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : November 28, 2016
In the last decades the impact of several variables on patients' social functioning has been investigated with conflicting findings. The involved variables might be grouped in three main categories: a) disease-related variables; b) personal resources; c) context-related factors. The present study is aimed to identify factors that affect most real-life functioning of subjects with schizophrenia and to assess negative and depressive symptoms, neurocognitive deficits and impairment of social cognition. Domains of negative symptoms and cognitive dysfunctions most associated with impairment of real-life functioning will be identified and appropriate data analyses will be carried out to define whether it has a direct or indirect impact on real-life functioning. The research units of Turin and Genua will also investigate the relationships between insight into the illness and real-life social functioning. The research unit of Genua will evaluate prevalence and course of depressive symptoms, insight impairment and neurocognitive deficits, and will define the relationships of these aspects with suicidal behavior and real-life social functioning. The Naples research unit n.1 will investigate the hypothesis that deficits of preattentive and perceptual functions underlie impaired social cognition and negative symptoms. An electrophysiological study will be carried out in which abnormalities of event-related components and gamma rhythm synchronization, relevant to preattentive and perceptual stages of information processing, will be studied as endophenotypes of the disorder.
The study will also investigate the heritability of disease-related variables by evaluating them in non-affected, first-degree relatives of subjects with schizophrenia. The research unit of Bari will test functionality of genetic variants relevant to dopaminergic signaling, that might confer risk for neurocognitive and related prefrontal dysfunction assessed by specific functional magnetic resonance imaging (fMRI) paradigms. The Naples research unit n. 6 will perform an association study between selected putative schizophrenia genes and specific psychometric, neurophysiological and neurocognitive schizophrenia endophenotypes; moreover, the research unit will search for de novo copy-number variations (CNV) as putative risk factors for schizophrenia or schizophrenia endophenotypes and for de novo protein-altering mutations that may contribute to the genetic component of schizophrenia endophenotypes. The Naples research unit n. 5 will be responsible for defining a standardized protocol for the assessment of medical comorbidities in subjects with schizophrenia. All psychiatric research units will contribute to assess the role of factors related to the context in modulating the impact of variables related to the disease on real-life social functioning.
|Condition or disease|
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|Study Type :||Observational|
|Actual Enrollment :||587 participants|
|Official Title:||Multicenter Study on Factors Influencing Real-life Social Functioning of People With a Diagnosis of Schizophrenia|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2016|
patients with schizophrenia
320 patients with a diagnosis of schizophrenia according to Diagnostic and Statistical Manual IV edition (DSM-IV) criteria, confirmed by the Structured Clinical Interview for DSM-IV - Patient Version (SCID -IP), will be included in the study.
unaffected first-degree relatives
240 unaffected first-degree relatives of the recruited patients (120 unaffected parents and 120 unaffected siblings)
320 healthy control subjects.
- Factors contributing to real life impairment in schizophrenia [ Time Frame: 36 months ]The primary objective of this study is to identify factors that affect most real-life functioning of patients with schizophrenia and define their relative contribution. To these aims, disease-related variables, personal resources and context-related factors will be evaluated as independent variables, while real-life functioning of the examined subjects will be the dependent variable. For each factor we will define whether its impact on real-life functioning is direct or indirect, i.e. mediated by the effects on another factor, in its turn associated with functioning.
- Relation between impairment of social cognition, negative symptoms and preattentive and perceptual deficits [ Time Frame: 36 months ]Verify, in a subgroup of subjects, the hypothesis that the impairment of some aspects of social cognition and negative symptoms, in particular the factor "anhedonia/asociality/avolition", are related to preattentive and perceptual deficits. Verify, in a subgroup of subjects, the impact of poor insight on social functioning of patients.
- Associations between schizophrenia candidate genes and endophenotypes of the disorder [ Time Frame: 36 months ]Demonstrate, in a subgroup of subjects, the existence of associations between schizophrenia candidate genes and endophenotypes of the disorder, in particular: associations between functional genetic variants related to dopaminergic transmission and indices of neurocognitive and prefrontal dysfunction, evaluated by functional MRI during a working memory task and associations between polymorphisms of genes regulating dopaminergic and glutamatergic transmission and electrophysiological endophenotypes
- Prevalence of physical comorbidities [ Time Frame: 36 months ]Prevalence of physical comorbidities in individuals with schizophrenia using a standardized protocol developed for this purpose
- Severity of physical comorbidities [ Time Frame: 36 months ]Investigate the severity of physical comorbidities in individuals with schizophrenia using a standardized protocol developed for this purpose
- Prevalence of depressive symptoms in individuals with schizophrenia [ Time Frame: 36 months ]Investigate, in a subgroup of subjects, the prevalence of depressive symptoms and the influence of these aspects on the emergence of suicidal behaviors.
- Course of depressive symptoms in individuals with schizophrenia [ Time Frame: 36 months ]Investigate, in a subgroup of subjects, the course of depressive symptoms and the influence of these aspects on the emergence of suicidal behaviors.
- Prevalence of poor insight and neurocognitive deficits in individuals with schizophrenia [ Time Frame: 36 months ]Investigate, in a subgroup of subjects, the prevalence poor insight and neurocognitive deficits, and the influence of these aspects on real life functioning
- Course of poor insight and neurocognitive deficits in individuals with schizophrenia [ Time Frame: 36 months ]Investigate, in a subgroup of subjects, the course poor insight and neurocognitive deficits, and the influence of these aspects on real life functioning
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166918
|University of Bari ITALY|
|University of Genova ITALY|
|Psychiatric University Hospital, University of Naples, SUN|
|Napoli, Italy, 80138|
|University of Torino ITALY|
|Study Director:||Mario Maj, MD, PhD||University of Naples, SUN|