An observational study in Women With Recent Diagnosis of Schizophrenia, Men With Recent Diagnosis of Schizophrenia and Healthy Women, sponsored by Corporacion Parc Tauli. Completed at 1 site in Spain. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by Corporacion Parc Tauli · Observational
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.
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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This study's enrollment of 80 is below the median of 210 across 573 observational studies indexed under Disease.
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Females and males with and without schizophrenia of recent diagnosis.
PARTICIPANTS WITH SCHIZOPHRENIA
Inclusion Criteria:
Exclusion Criteria:
PARTICIPANTS WITHOUT SCHIZOPHRENIA
Inclusion Criteria:
Exclusion Criteria:
Women with recent diagnosis of schizophrenia
Other: GENDER
Men with recent diagnosis of schizophrenia
Other: GENDER
Women without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis
Other: GENDER
Men without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis
Other: GENDER
Affective Theory of Mind
Measured by: Reading the Mind in the Eyes test (RMET)
Time frame: Through study completion, an average of 6 months
Cognitive Theory of Mind
Measured by: False belief stories
Time frame: Through study completion, an average of 6 months
Emotional Processing
Measured by: Pictures of Facial Affect (POFA)
Time frame: Through study completion, an average of 6 months
Psychosis Symptoms
Measured by: Positive and Negative Syndrome Scale
Time frame: Through study completion, an average of 6 months
Intelligence Quotient (IQ) in schizophrenia groups
Measured by: The abbreviated form of the Wechsler Adult Intelligence Scale (WAIS-III) (Blyder et al., 2000)
Time frame: Through study completion, an average of 6 months
Intelligence Quotient (IQ) in healthy groups
Measured by: The Vocabulary subtest (WAIS-III) in healthy participants.
Time frame: Through study completion, an average of 6 months
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Corporacion Parc Tauli