Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 3313 for:    schizophrenia

Factors Influencing Social Functioning of People With Schizophrenia (PRIN2014)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02166918
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : November 28, 2016
Sponsor:
Collaborators:
University of Turin, Italy
University of Bari
University of Genova
Information provided by (Responsible Party):
Prof. Silvana Galderisi, University of Campania "Luigi Vanvitelli"

Brief Summary:

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
Schizophrenia

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 587 participants
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
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)
healthy control
320 healthy control subjects.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Prevalence of physical comorbidities [ Time Frame: 36 months ]
    Prevalence of physical comorbidities in individuals with schizophrenia using a standardized protocol developed for this purpose

  4. 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


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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

  4. 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
In all subjects a blood sample of 20 ml will be withdrawn from a peripheral vein for genetic analyses.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Three-hundred-twenty patients (80 in each of the 4 recruitment units) with a diagnosis of schizophrenia according to DSM-IV criteria, confirmed by the Structured Clinical Interview for DSM-IV - Patient Version (SCID -IP), will be included in the study. One-hundred-twenty unaffected parents of the recruited patients (15 pairs of parents in each center), 120 unaffected siblings and 320 healthy control subjects, meeting the criteria listed below, will also be recruited.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166918


Locations
Layout table for location information
Italy
University of Bari ITALY
Bari, Italy
University of Genova ITALY
Genova, Italy
Psychiatric University Hospital, University of Naples, SUN
Napoli, Italy, 80138
University of Torino ITALY
Torino, Italy
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
University of Turin, Italy
University of Bari
University of Genova
Investigators
Layout table for investigator information
Study Director: Mario Maj, MD, PhD University of Naples, SUN

Publications:

Layout table for additonal information
Responsible Party: Prof. Silvana Galderisi, Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT02166918     History of Changes
Other Study ID Numbers: 2010XP2XR4
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prof. Silvana Galderisi, University of Campania "Luigi Vanvitelli":
Schizophrenia
Real-Life Functioning
Schizophrenia Endophenotypes
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders