Schizophrenia Clinical Trial
— PRIN2014Official title:
Multicenter Study on Factors Influencing Real-life Social Functioning of People With a Diagnosis of Schizophrenia
Verified date | November 2016 |
Source | Second University of Naples |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 587 |
Est. completion date | July 2016 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria for patients recruited from those attending the outpatient units of the
University Psychiatric Clinics of Naples, Turin, Genova and Bari: 1. diagnosis of schizophrenia according to DSM-IV, confirmed with the Structured Clinical Interview for DSMIV - Patient version (SCID-I-P), 2. age between 18 and 65 years Exclusion Criteria for patients: 1. a history of head trauma with loss of consciousness, 2. neurological disease, 3. history of alcoholism or substance abuse in the last six months, 4. pregnancy, 5. inability to provide informed consent, 6. moderate or severe mental retardation, 7. changes in antipsychotic therapy and hospitalization for exacerbation of symptoms in the 3 months prior to inclusion in the study. Exclusion criteria for unaffected relatives and healthy controls: 1. a positive personal history of psychiatric disorders and/or 2. a family history of mood or psychotic disorders or hospitalization in a psychiatric hospital. 3. any degree of mental retardation 4. current use of medications with central nervous system effects. 5. those listed in a-e for patients The Structured Clinical Interview for DSM IV Non Patients Version (SCID-NP-I) and the SCID II will be administered to both healthy controls and family members. |
Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Italy | University of Bari ITALY | Bari | |
Italy | University of Genova ITALY | Genova | |
Italy | Psychiatric University Hospital, University of Naples, SUN | Napoli | |
Italy | University of Torino ITALY | Torino |
Lead Sponsor | Collaborator |
---|---|
Second University of Naples | University of Bari, University of Genova, University of Turin, Italy |
Italy,
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Galderisi S, Davidson M, Kahn RS, Mucci A, Boter H, Gheorghe MD, Rybakowski JK, Libiger J, Dollfus S, López-Ibor JJ, Peuskens J, Hranov LG, Fleischhacker WW; EUFEST group.. Correlates of cognitive impairment in first episode schizophrenia: the EUFEST study. Schizophr Res. 2009 Dec;115(2-3):104-14. doi: 10.1016/j.schres.2009.09.022. — View Citation
Galderisi S, Maj M. Deficit schizophrenia: an overview of clinical, biological and treatment aspects. Eur Psychiatry. 2009 Dec;24(8):493-500. doi: 10.1016/j.eurpsy.2009.03.001. Review. — View Citation
Maj M. Physical health care in persons with severe mental illness: a public health and ethical priority. World Psychiatry. 2009 Feb;8(1):1-2. — View Citation
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Monteleone P, Bifulco M, Di Filippo C, Gazzerro P, Canestrelli B, Monteleone F, Proto MC, Di Genio M, Grimaldi C, Maj M. Association of CNR1 and FAAH endocannabinoid gene polymorphisms with anorexia nervosa and bulimia nervosa: evidence for synergistic effects. Genes Brain Behav. 2009 Oct;8(7):728-32. doi: 10.1111/j.1601-183X.2009.00518.x. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prevalence of depressive symptoms in individuals with schizophrenia | Investigate, in a subgroup of subjects, the prevalence of depressive symptoms and the influence of these aspects on the emergence of suicidal behaviors. | 36 months | No |
Other | Course of depressive symptoms in individuals with schizophrenia | Investigate, in a subgroup of subjects, the course of depressive symptoms and the influence of these aspects on the emergence of suicidal behaviors. | 36 months | No |
Other | Prevalence of poor insight and neurocognitive deficits in individuals with schizophrenia | Investigate, in a subgroup of subjects, the prevalence poor insight and neurocognitive deficits, and the influence of these aspects on real life functioning | 36 months | No |
Other | Course of poor insight and neurocognitive deficits in individuals with schizophrenia | Investigate, in a subgroup of subjects, the course poor insight and neurocognitive deficits, and the influence of these aspects on real life functioning | 36 months | No |
Primary | Factors contributing to real life impairment in schizophrenia | 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. | 36 months | No |
Secondary | Relation between impairment of social cognition, negative symptoms and preattentive and perceptual deficits | 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. | 36 months | No |
Secondary | Associations between schizophrenia candidate genes and endophenotypes of the disorder | 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 | 36 months | No |
Secondary | Prevalence of physical comorbidities | Prevalence of physical comorbidities in individuals with schizophrenia using a standardized protocol developed for this purpose | 36 months | No |
Secondary | Severity of physical comorbidities | Investigate the severity of physical comorbidities in individuals with schizophrenia using a standardized protocol developed for this purpose | 36 months | No |
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