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NCT02896374 Clinical Trial

Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia

Schizophrenia Clinical Trial

— SERC  

Official title:
Normal and Abnormal Event Related Potentials During Attribution of Intentions to Others and Resolution of Emotional Conflicts in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02896374
Other study ID # P11/16_SERC
Secondary ID
Status Completed
Phase N/A
First received August 19, 2016
Last updated March 21, 2018
Start date March 2013
Est. completion date December 2017

Study information
Verified date March 2018
Source Versailles Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Case-control comparison of clinical population, interventional and single-center research.

Description:

The main objective of this study is to define and characterize electrophysiological markers of the existing social cognition disorders in schizophrenia. Two groups of subjects are recorded : schizophrenic patients and healthy controls. Visual reinforcement effect during theory of mind judgment is tested.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

Written informed consent French mother tongue Schizophrenia diagnosis according to DSM-IV-R for the patient group

Exclusion Criteria:

Coma history, epilepsy, head trauma with loss knowledge greater 10 min ECT older than 1 month DSM-4 R criteria of toxic addiction in the last 6 months Deafness or blindness Scalp pathology Intracranial implanted device

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Theory of mind without visual cues
Theory of mind stimulation without visual reinforcement while performing EEG recordings
• Theory of mind without visual cues
Theory of mind stimulation with visual reinforcement while performing EEG recordings

Locations
Country Name City State
France Centre Hospitalier de Versailles Le Chesnay

Sponsors (1)
Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event related electric amplitudes Scalp EEG recordings (microvolts) with respect to average or vertex references Day 0
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