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Completed

NCT Number: NCT02901015

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont Ferrand, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment battery A

Behavioral

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

Assessment battery B

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Official study title

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

Acronym: EVACO

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2016
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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