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

Versailles Hospital173 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

173

Conditions

Schizophrenia

Interventions

Assessment battery ABEHAVIORAL

Social cognition tests version "A" are administered to the patients

Assessment battery BBEHAVIORAL

Social cognition tests version "B" are administered to the patients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (8)

CHU de Clermont Ferrand

Clermont-Ferrand, France

Hôpital Louis Mourier

Colombes, France

Hôpital Henri Mondor

Créteil, France

Centre Hospitalier de Versailles

Le Chesnay, France

Outcomes

Primary Outcomes

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.

Time frame: Day 0, Month 12

Secondary Outcomes

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)

Time frame: 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

Time frame: Day 0, Month 12

Data from ClinicalTrials.gov

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