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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment battery A
Assessment battery B
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizophrenia focused on measuring schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont Ferrand
  • Hôpital Louis Mourier
  • Hôpital Henri Mondor
  • Centre Hospitalier de Versailles
  • Hôpital Sainte Marguerite
  • CHRU de Montpellier
  • Centre Hospitalier Alpes Isère
  • CHU de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Schizophrenic patients group 1

Schizophrenic patients group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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

Full Information

First Posted
August 19, 2016
Last Updated
March 21, 2018
Sponsor
Versailles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02901015
Brief Title
Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning
Acronym
EVACO
Official Title
Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schizophrenic patients group 1
Arm Type
Other
Arm Description
80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).
Arm Title
Schizophrenic patients group 2
Arm Type
Other
Arm Description
80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).
Intervention Type
Behavioral
Intervention Name(s)
Assessment battery A
Intervention Description
Social cognition tests version "A" are administered to the patients
Intervention Type
Behavioral
Intervention Name(s)
Assessment battery B
Intervention Description
Social cognition tests version "B" are administered to the patients
Primary Outcome Measure Information:
Title
Change in cognitive skills
Description
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 Outcome Measure Information:
Title
Change in Functioning
Description
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
Title
Change in Psychotic symptoms
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92701
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Hôpital Sainte Marguerite
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
CHRU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Alpes Isère
City
Saint Egrève
ZIP/Postal Code
38120
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

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

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