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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Assessment battery A; Behavioral: Assessment battery B

• Registration Number: NCT02901015
• Lead Sponsor: Versailles Hospital

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-15
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Schizophrenic patients group 1	Assessment battery A	80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).
Schizophrenic patients group 2	Assessment battery B	80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Centre Hospitalier de Versailles; 🇫🇷 Le Chesnay, France

CHU de Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

Hôpital Louis Mourier; 🇫🇷 Colombes, France

Hôpital Sainte Marguerite; 🇫🇷 Marseille, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHRU de Montpellier; 🇫🇷 Montpellier, France

Centre Hospitalier Alpes Isère; 🇫🇷 Saint Egrève, France