Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning

Study Overview
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Brief Summary
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Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval.

Detailed Description
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The main objective is evaluation and validation of social cognition battery, characterizing the psychometric properties (validity, sensitivity to change) measures in a cohort of schizophrenic patients. Other objective is to demonstrate that the various components operating at T0 and T12 months of schizophrenic patients, as an external validator, are significantly explained by social cognition performance given the third known factors : neuropsychological, sociodemographic, disease course, and clinical status. Search and model relationships between the measured variables.

Official Title
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Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Assessment battery A
* Behavioral: Assessment battery B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenia or schizoaffective disorder Age > 18 years and < 65 years Patient's state allows cognitive and neuropsychological assessment Affiliated to a social security system (beneficiary or legal). Informed consent signature (patients under guardianship may be included with written permission from their legal representative). Exclusion Criteria: Alcohol dependence or current toxic Electroconvulsivotherapy (less than 6 months) Serious head trauma (become unconscious), epilepsy or neurological disorder significant or evolutionary Invalidating and uncorrected visual disorder Invalidating and not paired hearing Actually hospitalized under constraint Patient not able to come to different evaluations, or who plan to change medical care in the following year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Schizophrenic patients group 1<br>80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France). | Behavioral: Assessment battery A<br>* Social cognition tests version A are administered to the patients<br>|
| Other: Schizophrenic patients group 2<br>80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France). | Behavioral: Assessment battery B<br>* Social cognition tests version B are administered to the patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive skills | Change in the aggregates (average) of standardized performance levels : z-scores of Theory of mind (V-COMICS, V-SIR, SPEX), z-scores of empathy (QCAE), z-scores of facial affect recognition (TREF), z-scores of metacognition (V-COMICS meta), Intelligence quotient (WAIS-III), z-scores of treatment speed, z-scores of memory spans, z-scores of verbal memory, z-scores of visual memory, z-scores of attention/vigilance, z-scores of divided attention, z-scores of executive functions. | Day 0, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functioning | Change in the aggregates (average) of standardized functioning assessment: z-scores of social functioning, z-scores of general functioning (PSPS), and z-scores of help acceptance subscales (M-SEQ) | Day 0, Month 12 | 
| Change in Psychotic symptoms | Change in the aggregates (average) of standardized symptomatology and clinical dimensions: z-scores of Schizophrenic syndromes, depressive syndrome and manic syndrome (PANSS), z-scores of observance scale (MARS/BARS), z-scores of insight (Birchwood), z-scores of antipsychotic medication doses | Day 0, Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia