Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Versailles Hospital
- Enrollment
- 173
- Locations
- 8
- Primary Endpoint
- Change in cognitive skills
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eric BRUNET
Investigator coordinator
Versailles Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in cognitive skills
Time Frame: 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 Outcomes
- Change in Functioning(Day 0, Month 12)
- Change in Psychotic symptoms(Day 0, Month 12)