Gender Differences in Social Cognition in Patients With Schizophrenia of Recent Diagnosis and Healthy Controls Subjects

NCT ID: NCT02575209

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-07-31

Brief Summary

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Individuals with schizophrenia have important and persistent deficits in multiple neurocognitive domains as well as in the Social Cognition (SC). SC refers to the mental operations underlying social behavior, and it is understood as a multidimensional construct that comprises emotional processing (EP), social perspective and knowledge, attributional bias and theory of mind (ToM) or mentalizing. Mentalizing and EP skills have been the two most studied subdomains of SC in schizophrenia. Both domains have been found to be impaired in chronic schizophrenia patients as well as in patients in early stages of the illness. In this context, although negative symptoms may play and important role, females seem to perform better than males in ToM and EP tasks, suggesting the presence of gender differences in the SC skills in patients with schizophrenia. However, to our knowledge, there are no studies that have explored the gender-related differences between cognitive and affective ToM and its relationship with the EP performance in schizophrenia patients of recent diagnosis comparing with healthy subjects.

In this line, the main objective of this project is to analyze the influence of gender in the cognitive and affective ToM abilities, in a group of patients with schizophrenia in early stages of the illness comparing with healthy subjects. Secondarily, this study pretends to explore the association between EP skills and affective ToM tasks performance in males and females with and without recent diagnosis of schizophrenia.

Detailed Description

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50 patients (25 men and 25 women) will be recruited to participate in the study. Diagnosis of schizophrenia or schizoaffective disorder will be obtained through the medical records of each patient, and confirmed with the administration of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) (American Psychiatric Association, 1994) by an expert psychiatrist. The same professional will confirm the inclusion and exclusion criteria, and administrate and correct the Positive and Negative Syndrome Scale (PANNS) of all patients. An expert neuropsychologist will administrate and correct the the abbreviated form of the Wechsler Adult Intelligence Scale (WAIS-III) and the ToM and EP tasks.

In a second phase, a total of 50 healthy people (25 men and 25 women), matched according to age and years of schooling with the previous group, will be recruited. An expert neuropsychologist will confirm the inclusion and exclusion criteria, and administrate and correct the Vocabulary subtests of the WAIS-III and ToM and EP tasks.

All of them will be informed about the characteristics of the study before participating, and will sign an informed consent approved by the ethical committee of the hospital. The subjects will participate voluntarily.

4 groups ANOVAs will be performed for studying differences in affective and cognitive ToM between the groups (1-Women With Recent Diagnosis of Schizophrenia; 2-Men With Recent Diagnosis of Schizophrenia; 3-Healthy Women; 4-Healthy Men). Linear regression models will be performed for exploring the relationship between gender, negative symptoms (only in the schizophrenia sample) and EP (independents variables) in affective ToM (dependent variable).

Conditions

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Women With Recent Diagnosis of Schizophrenia Men With Recent Diagnosis of Schizophrenia Healthy Women Healthy Men

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Women schiz.

Women with recent diagnosis of schizophrenia

GENDER

Intervention Type OTHER

Men schiz.

Men with recent diagnosis of schizophrenia

GENDER

Intervention Type OTHER

Women healthy

Women without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis

GENDER

Intervention Type OTHER

Men healthy

Men without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis

GENDER

Intervention Type OTHER

Interventions

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GENDER

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients meeting DSM-IV criteria for schizophrenia or schizoaffective disorder with less than 5 years of evolution of the disorder.
* Being an outpatient for at least 4 weeks before the study (clinical stability).
* No changes in the antipsychotic medication during the month before the study.
* Score less than 4 in the P1, P2 and P3 items of the PANSS.
* Score less than 4 in the Calgary Depression Scale.


• Healthy people over 18 years old.

Exclusion Criteria

* Intellectual disability (IQ\<70).
* History of brain damage.
* History of substance abuse (except nicotine or caffeine) during the last 12 months before the study.

PARTICIPANTS WITHOUT SCHIZOPHRENIA


* Sensory impairment: visual or hearing disabilities.
* Intellectual disability (IQ\<70).
* History of neurologic disease.
* History of psychiatric disorder.
* History of substance abuse (except nicotine or caffeine) during the last 12 months before the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Sol Fernandez-Gonzalo

Neuropsychologist researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sol Fernandez-Gonzalo, PhD

Role: PRINCIPAL_INVESTIGATOR

Corporació Parc Taulí

Locations

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Corporació Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

References

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Abu-Akel A, Bo S. Superior mentalizing abilities of female patients with schizophrenia. Psychiatry Res. 2013 Dec 30;210(3):794-9. doi: 10.1016/j.psychres.2013.09.013. Epub 2013 Oct 5.

Reference Type BACKGROUND
PMID: 24103909 (View on PubMed)

Bora E, Pantelis C. Theory of mind impairments in first-episode psychosis, individuals at ultra-high risk for psychosis and in first-degree relatives of schizophrenia: systematic review and meta-analysis. Schizophr Res. 2013 Mar;144(1-3):31-6. doi: 10.1016/j.schres.2012.12.013. Epub 2013 Jan 21.

Reference Type BACKGROUND
PMID: 23347949 (View on PubMed)

Bozikas VP, Andreou C. Longitudinal studies of cognition in first episode psychosis: a systematic review of the literature. Aust N Z J Psychiatry. 2011 Feb;45(2):93-108. doi: 10.3109/00048674.2010.541418.

Reference Type BACKGROUND
PMID: 21320033 (View on PubMed)

Green MF, Penn DL, Bentall R, Carpenter WT, Gaebel W, Gur RC, Kring AM, Park S, Silverstein SM, Heinssen R. Social cognition in schizophrenia: an NIMH workshop on definitions, assessment, and research opportunities. Schizophr Bull. 2008 Nov;34(6):1211-20. doi: 10.1093/schbul/sbm145. Epub 2008 Jan 8.

Reference Type BACKGROUND
PMID: 18184635 (View on PubMed)

Kohler CG, Turner TH, Bilker WB, Brensinger CM, Siegel SJ, Kanes SJ, Gur RE, Gur RC. Facial emotion recognition in schizophrenia: intensity effects and error pattern. Am J Psychiatry. 2003 Oct;160(10):1768-74. doi: 10.1176/appi.ajp.160.10.1768.

Reference Type BACKGROUND
PMID: 14514489 (View on PubMed)

Mesholam-Gately RI, Giuliano AJ, Goff KP, Faraone SV, Seidman LJ. Neurocognition in first-episode schizophrenia: a meta-analytic review. Neuropsychology. 2009 May;23(3):315-36. doi: 10.1037/a0014708.

Reference Type BACKGROUND
PMID: 19413446 (View on PubMed)

Savla GN, Vella L, Armstrong CC, Penn DL, Twamley EW. Deficits in domains of social cognition in schizophrenia: a meta-analysis of the empirical evidence. Schizophr Bull. 2013 Sep;39(5):979-92. doi: 10.1093/schbul/sbs080. Epub 2012 Sep 4.

Reference Type BACKGROUND
PMID: 22949733 (View on PubMed)

Navarra-Ventura G, Fernandez-Gonzalo S, Turon M, Pousa E, Palao D, Cardoner N, Jodar M. Gender Differences in Social Cognition: A Cross-Sectional Pilot Study of Recently Diagnosed Patients with Schizophrenia and Healthy Subjects. Can J Psychiatry. 2018 Aug;63(8):538-546. doi: 10.1177/0706743717746661. Epub 2017 Dec 7.

Reference Type DERIVED
PMID: 29216439 (View on PubMed)

Other Identifiers

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2015534

Identifier Type: -

Identifier Source: org_study_id

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