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

Versailles Hospital

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: Assessment battery A; Behavioral: Assessment battery B

Study type: Interventional

Funder types: Other

Identifiers

NCT02901015

P11/34_EVACO

Details and patient eligibility

About

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

Full 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.

Enrollment: 173 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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173 participants in 2 patient groups

Schizophrenic patients group 1

Other group

Description:

80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).

Treatment:

Behavioral: Assessment battery A

Schizophrenic patients group 2

Other group

Description:

80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).

Treatment:

Behavioral: Assessment battery B