Study of Electrophysiological Markers Related to the Cognitive and Affective Processes Behind Empathic Behaviour in Schizophrenic Spectrum Disorder
SchizoEmp
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Oct 2020
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedStudy Start
First participant enrolled
October 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
March 24, 2025
March 1, 2025
6 years
February 18, 2020
March 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evoked Related Potentials
Amplitude of modulations of the electrophysiological signal
On the first day
Study Arms (2)
CONTROLLED SUBJECTS
EXPERIMENTALIn this arm, only controlled subjects (pathological-free) will be investigated.
PATIENTS
EXPERIMENTALIn this arm, only patients with scyzophrenic syndrome will be investigated.
Interventions
Evoked Related Potentials are measured by means of electroencephalography. During this measure, 2 informatic task will be performed to evaluated evoked related potentials.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Pasteur - Service de Psychiatrie
Nice, 06001, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 20, 2020
Study Start
October 10, 2020
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
March 24, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share