Factors Influencing Social Functioning of People With Schizophrenia

NCT02166918 | Completed DMC

• 1 other identifier: 2010XP2XR4
• Study Type: observational
• Target: 587
• Locations: 1 country
• Sites: 4

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Real-Life Functioning; Schizophrenia Endophenotypes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Relation between impairment of social cognition, negative symptoms and preattentive and perceptual deficits

  36 months

• Associations between schizophrenia candidate genes and endophenotypes of the disorder

  36 months

• Prevalence of physical comorbidities

  36 months

• Severity of physical comorbidities

  36 months

Other Outcomes (4)

• Prevalence of depressive symptoms in individuals with schizophrenia

  36 months

• Course of depressive symptoms in individuals with schizophrenia

  36 months

• Prevalence of poor insight and neurocognitive deficits in individuals with schizophrenia

  36 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• diagnosis of schizophrenia according to DSM-IV, confirmed with the Structured Clinical Interview for DSMIV - Patient version (SCID-I-P),
• age between 18 and 65 years

You may not qualify if:

• a history of head trauma with loss of consciousness,
• neurological disease,
• history of alcoholism or substance abuse in the last six months,
• pregnancy,
• inability to provide informed consent,
• moderate or severe mental retardation,
• a positive personal history of psychiatric disorders and/or
• a family history of mood or psychotic disorders or hospitalization in a psychiatric hospital.
• any degree of mental retardation
• current use of medications with central nervous system effects.
• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• University of Turin, Italy: collaborator
• University of Bari: collaborator
• University of Genova: collaborator

Study Sites (4)

Psychiatric University Hospital, University of Naples, SUN

Napoli, Napoli, 80138, Italy

Location

University of Bari ITALY

Bari, Italy

Location

University of Genova ITALY

Genova, Italy

Location

University of Torino ITALY

Torino, Italy

Location

Related Publications (8)

• 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. Epub 2009 Jun 26.

  PMID: 19659925 BACKGROUND

• Galderisi S, Bucci P, Mucci A, Kirkpatrick B, Pini S, Rossi A, Vita A, Maj M. Categorical and dimensional approaches to negative symptoms of schizophrenia: focus on long-term stability and functional outcome. Schizophr Res. 2013 Jun;147(1):157-162. doi: 10.1016/j.schres.2013.03.020. Epub 2013 Apr 19.

  PMID: 23608244 BACKGROUND

• Maj M. Understanding the pathophysiology of schizophrenia: are we on the wrong or on the right track? Schizophr Res. 2011 Apr;127(1-3):20-1. doi: 10.1016/j.schres.2011.01.002. Epub 2011 Feb 1. No abstract available.

  PMID: 21277744 BACKGROUND

• Maj M. The rights of people with mental disorders: WPA perspective. Lancet. 2011 Oct 29;378(9802):1534-5. doi: 10.1016/S0140-6736(11)60745-9. Epub 2011 Oct 16. No abstract available.

  PMID: 22008423 BACKGROUND

• Monteleone P, Martiadis V, Maj M. Management of schizophrenia with obesity, metabolic, and endocrinological disorders. Psychiatr Clin North Am. 2009 Dec;32(4):775-94. doi: 10.1016/j.psc.2009.08.003.

  PMID: 19944883 BACKGROUND

• 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. doi: 10.1002/j.2051-5545.2009.tb00196.x. No abstract available.

  PMID: 19293947 BACKGROUND

• 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. Epub 2009 Jun 23.

  PMID: 19553087 BACKGROUND

• Galderisi S, Davidson M, Kahn RS, Mucci A, Boter H, Gheorghe MD, Rybakowski JK, Libiger J, Dollfus S, Lopez-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. Epub 2009 Oct 12.

  PMID: 19822407 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Mario Maj, MD, PhD

  University of Naples, SUN

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)