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

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: NCT02575209
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Sol Fernandez-Gonzalo, Corporacion Parc Tauli

Brief Summary:

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.


Condition or disease Intervention/treatment
Women With Recent Diagnosis of Schizophrenia Men With Recent Diagnosis of Schizophrenia Healthy Women Healthy Men Other: GENDER

Detailed Description:

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).

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Gender Differences in Social Cognition in Patients With Schizophrenia of Recent Diagnosis and Healthy Controls Subjects
Study Start Date : September 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
Women schiz.
Women with recent diagnosis of schizophrenia
Other: GENDER
Men schiz.
Men with recent diagnosis of schizophrenia
Other: GENDER
Women healthy
Women without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis
Other: GENDER
Men healthy
Men without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis
Other: GENDER



Primary Outcome Measures :
  1. Affective Theory of Mind [ Time Frame: Through study completion, an average of 6 months ]
    Measured by: Reading the Mind in the Eyes test (RMET)

  2. Cognitive Theory of Mind [ Time Frame: Through study completion, an average of 6 months ]
    Measured by: False belief stories


Secondary Outcome Measures :
  1. Emotional Processing [ Time Frame: Through study completion, an average of 6 months ]
    Measured by: Pictures of Facial Affect (POFA)

  2. Psychosis Symptoms [ Time Frame: Through study completion, an average of 6 months ]
    Measured by: Positive and Negative Syndrome Scale


Other Outcome Measures:
  1. Intelligence Quotient (IQ) in schizophrenia groups [ Time Frame: Through study completion, an average of 6 months ]
    Measured by: The abbreviated form of the Wechsler Adult Intelligence Scale (WAIS-III) (Blyder et al., 2000)

  2. Intelligence Quotient (IQ) in healthy groups [ Time Frame: Through study completion, an average of 6 months ]
    Measured by: The Vocabulary subtest (WAIS-III) in healthy participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Females and males with and without schizophrenia of recent diagnosis.
Criteria

PARTICIPANTS WITH SCHIZOPHRENIA

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.

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

Inclusion Criteria:

• Healthy people over 18 years old.

Exclusion Criteria:

  • 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.

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): NCT02575209


Locations
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Spain
Corporació Parc Taulí
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Sol Fernandez-Gonzalo, PhD Corporació Parc Taulí
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sol Fernandez-Gonzalo, Neuropsychologist researcher, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02575209    
Other Study ID Numbers: 2015534
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders