Schizophrenia
Conditions
Keywords
schizophrenia
Brief summary
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
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.
Interventions
BEHAVIORALAssessment battery A
Social cognition tests version A are administered to the patients
BEHAVIORALAssessment battery B
Social cognition tests version B are administered to the patients
Sponsors
Versailles Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive skills | Day 0, Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functioning | Day 0, Month 12 | 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) |
| Change in Psychotic symptoms | Day 0, Month 12 | 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 |
Countries
France
Outcome results
None listed