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

Schizophrenia Clinical Trial

— SchizoEmp  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278339
• Other study ID #: 19-PP-14
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: October 2025

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Bruno GIORDANA, PH
• Phone: 4.92.03.87.75
• Email: giordana.b[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Hôpital Pasteur - Service de Psychiatrie	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evoked Related Potentials	Amplitude of modulations of the electrophysiological signal	On the first day