Healthy Men Clinical Trial
Official title:
Gender Differences in Social Cognition in Patients With Schizophrenia of Recent Diagnosis and Healthy Controls Subjects
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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