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

Not Applicable

Recruiting

• Conditions: Schizophrenia
• Interventions: Other: Evoked Related Potentials

• Registration Number: NCT04278339
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2020-10-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROLLED SUBJECTS	Evoked Related Potentials	In this arm, only controlled subjects (pathological-free) will be investigated.
PATIENTS	Evoked Related Potentials	In this arm, only patients with scyzophrenic syndrome will be investigated.

Primary Outcome Measures

Name	Time	Method
Evoked Related Potentials	On the first day	Amplitude of modulations of the electrophysiological signal

Trial Locations

Locations (1)

Hôpital Pasteur - Service de Psychiatrie; 🇫🇷 Nice, France