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

Schizophrenia Clinical Trial

— EVACO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901015
• Other study ID #: P11/34_EVACO
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: March 21, 2018
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Assessment battery A
Social cognition tests version "A" are administered to the patients
• Assessment battery B
Social cognition tests version "B" are administered to the patients

Locations

Country	Name	City	State
France	CHU de Clermont Ferrand	Clermont Ferrand
France	Hôpital Louis Mourier	Colombes
France	Hôpital Henri Mondor	Créteil
France	Centre Hospitalier de Versailles	Le Chesnay
France	Hôpital Sainte Marguerite	Marseille
France	CHRU de Montpellier	Montpellier
France	Centre Hospitalier Alpes Isère	Saint Egrève
France	CHU de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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