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

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Assessment battery A; Behavioral: Assessment battery B

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 Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont Ferrand, France, 63003
    • CHU de Clermont Ferrand
  • Colombes, France, 92701
    • Hôpital Louis Mourier
  • Créteil, France, 94010
    • Hopital Henri Mondor
  • Le Chesnay, France, 78150
    • Centre Hospitalier De Versailles
  • Marseille, France, 13274
    • Hôpital Sainte Marguerite
  • Montpellier, France, 34295
    • CHRU de Montpellier
  • Saint Egrève, France, 38120
    • Centre Hospitalier Alpes Isère
  • Strasbourg, France, 67098
    • CHU de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Schizophrenic patients group 1; 80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).	Behavioral: Assessment battery A; Social cognition tests version "A" are administered to the patients
Other: Schizophrenic patients group 2; 80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).	Behavioral: Assessment battery B; Social cognition tests version "B" are administered to the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0, Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Day 0, Month 12

Collaborators and Investigators

• Sponsor: Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: P11/34_EVACO