Study of Electrophysiological Markers Related to the Cognitive and Affective Processes Behind Empathic Behaviour in Schizophrenic Spectrum Disorder

NCT ID: NCT04278339

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2026-10-31

Brief Summary

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Disorders of social cognition, and empathy more specifically, are at the heart of schizophrenic pathology in that they are strongly linked to the social handicap of patients. It is therefore necessary to refine our knowledge of the cognitive and affective processes behind this empathic disorder and to identify objective and easily measurable markers (related to brain functioning collected by electroencephalography) of these processes with the subsequent aim of improving their management. It is also relevant to question the trait/status nature of these empathic disorders by studying these markers in individuals presenting more or less marked schizotypic traits and therefore more or less at risk of developing schizophrenia. Studying the possibility that empathy disorders may be part of the factors of developmental vulnerability for schizophrenia and identifying objective markers of this vulnerability could allow, in case of development of the pathology, a more rapid diagnosis and a more effective management.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CONTROLLED SUBJECTS

In this arm, only controlled subjects (pathological-free) will be investigated.

Group Type EXPERIMENTAL

Evoked Related Potentials

Intervention Type OTHER

Evoked Related Potentials are measured by means of electroencephalography. During this measure, 2 informatic task will be performed to evaluated evoked related potentials.

PATIENTS

In this arm, only patients with scyzophrenic syndrome will be investigated.

Group Type EXPERIMENTAL

Evoked Related Potentials

Intervention Type OTHER

Evoked Related Potentials are measured by means of electroencephalography. During this measure, 2 informatic task will be performed to evaluated evoked related potentials.

Interventions

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Evoked Related Potentials

Evoked Related Potentials are measured by means of electroencephalography. During this measure, 2 informatic task will be performed to evaluated evoked related potentials.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Common to all: good command of the French language, right-handed.
* Specific to patients: diagnosis of schizophrenia or schizoaffective disorder, clinical state stabilized according to the treating psychiatrist.

Exclusion Criteria

* Common to all: having suffered a head injury with loss of consciousness lasting more than 5 minutes, participating in another project at the time of the present study, presenting an addiction to a toxic substance (excluding tobacco), presenting a mental retardation or neurological disorder (verified by a pre-recruitment interview and the administration of the Mini International Neuropsychiatric Interview for control subjects and on the basis of the information in the medical file for patients).
* Patient-specific: significant change (according to the doctor) in treatment in the previous month, currently hospitalized.
* Specific to controls: taking a psychoactive drug, having a mental disorder, being first-degree related to a patient with a disorder other than schizophrenia or schizoaffective disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Pasteur - Service de Psychiatrie

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Bruno GIORDANA, PH

Role: CONTACT

4.92.03.87.75 ext. +33

Facility Contacts

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Bruno GIORDANA, PH

Role: primary

4.92.03.87.75 ext. +33

Other Identifiers

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19-PP-14

Identifier Type: -

Identifier Source: org_study_id

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