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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Recruiting
CT.gov ID
NCT04278339
Collaborator
(none)
70
1
2
24
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Evoked Related Potentials
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study of Electrophysiological Markers Related to the Cognitive and Affective Processes Behind Empathic Behaviour in Schizophrenic Spectrum Disorder
Anticipated Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CONTROLLED SUBJECTS

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

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.

Experimental: PATIENTS

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

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.

Outcome Measures

Primary Outcome Measures

  1. Evoked Related Potentials [On the first day]

    Amplitude of modulations of the electrophysiological signal

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Pasteur - Service de Psychiatrie Nice France 06001

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT04278339
Other Study ID Numbers:
  • 19-PP-14
First Posted:
Feb 20, 2020
Last Update Posted:
Jul 9, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2020