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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Schizophrenic patients group 1 | Other | 80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France). |
|
| Schizophrenic patients group 2 | Other | 80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment battery A | Behavioral | Social cognition tests version "A" are administered to the patients |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont Ferrand | Clermont-Ferrand | 63003 | France | |||
| Hôpital Louis Mourier |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Assessment battery B | Behavioral | Social cognition tests version "B" are administered to the patients |
|
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 |
| Colombes |
| 92701 |
| France |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| Centre Hospitalier de Versailles | Le Chesnay | 78150 | France |
| Hôpital Sainte Marguerite | Marseille | 13274 | France |
| CHRU de Montpellier | Montpellier | 34295 | France |
| Centre Hospitalier Alpes Isère | Saint Egrève | 38120 | France |
| CHU de Strasbourg | Strasbourg | 67098 | France |