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

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ClinicalTrials.gov Identifier: NCT02901015
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Eric BRUNET, 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Assessment battery A Behavioral: Assessment battery B Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)
Actual Study Start Date : April 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Change in cognitive skills [ Time Frame: 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 :
  1. Change in Functioning [ Time Frame: 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)

  2. Change in Psychotic symptoms [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901015


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

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Responsible Party: Eric BRUNET, Investigator coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT02901015     History of Changes
Other Study ID Numbers: P11/34_EVACO
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Keywords provided by Eric BRUNET, Versailles Hospital:
schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders