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

NCT02901015 | Completed

• 1 other identifier: P11/34_EVACO
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 8

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.

Conditions

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Functioning

  Day 0, Month 12

• Change in Psychotic symptoms

  Day 0, Month 12

Study Arms (2)

Schizophrenic patients group 1

OTHER

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

Behavioral: Assessment battery A

Schizophrenic patients group 2

OTHER

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

Behavioral: Assessment battery B

Interventions

Assessment battery A BEHAVIORAL

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

Schizophrenic patients group 1

Assessment battery B BEHAVIORAL

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

Schizophrenic patients group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (8)

CHU de Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Hôpital Louis Mourier

Colombes, 92701, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

Hôpital Sainte Marguerite

Marseille, 13274, France

Location

CHRU de Montpellier

Montpellier, 34295, France

Location

Centre Hospitalier Alpes Isère

Saint Egrève, 38120, France

Location

CHU de Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator coordinator

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 15, 2016
• Study Start: April 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

FR (8)