ERPs-PSY: Psychiatric Disorders and Electrophysiological Markers

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT02329119
Collaborator
(none)
200
1
2
41
4.9

Study Details

Study Description

Brief Summary

Schizophrenia is considered as the most frequent and the most severe chronic psychotic disorder. Its evolutionary modes and its clinical symptomatology remain particularly heterogeneous. Moreover, the brain processes involved in schizophrenia are still far from being clearly understood. Current empirical studies provide a mean duration comprised between 1 and 3 years without any specific diagnosis or treatment. These diagnosis issues are partly based on difficulties in the early distinction between schizophrenia and bipolar affective disorders (BD).

These results emphasize the necessity of new early indices (or endophenotypes). Such markers are intended to be more specific than classical clinical manifestations. In other words, they have to be absent among patients with differential diagnosis, such as BD. Among other possible early indices, several electrophysiological disturbances have been explored.

Our study is designed to mainly describe the N400 component among patients with schizophrenia or BD. This component is classically interpreted as indexing the integration the meaning of a linguistic stimulus in its preceding context. Our main hypothesis aims to show a specific alteration of N400 component among patients with schizophrenia when compared to participants with BD.

The second aim of this study concerns the exploration of four other event related potentials (ERPs) among patients with schizophrenia or BD:

  • the P50 component, involved in early sensory gating processes,

  • the P300 component, thought to reflect attentional resource allocation and working memory updating of stimulus context,

  • the P600 component, elicited during same paradigms than N400, and reflecting their syntactic congruity.

  • the CNV (Contingent Negative Variation), reflecting processes of motor anticipation

Regarding to their potential 'endophenotypes' status, our aim consists in comparing the N400 and three other ERPs among patients with schizophrenia or bipolar affective disorder. Since the schizophrenic specificity of such ERPs alterations still remains rarely studied, we also propose to describe the possible relations between these ERPs results and clinical scores observed among patients.

Condition or Disease Intervention/Treatment Phase
  • Other: electrophysiological recordings
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Psychiatric Disorders and Electrophysiological Markers
Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Feb 1, 2018
Anticipated Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: G1-SCZ

patients with schizophrenia as defined in DSM IV-TR

Other: electrophysiological recordings

Active Comparator: G2-TAB

patients with bipolar affective disorder (BD) type I as defined by the DSM IV-TR

Other: electrophysiological recordings

Outcome Measures

Primary Outcome Measures

  1. amplitude (in µV) of negativity observed the highest between 250 and 500 ms for the N400 component of Event Related Potentials (ERP) [1 day]

    amplitude (in µV) of negativity observed the highest between 250 and 500 ms for the N400 component of Event Related Potentials (ERP) recorded from nine electrodes. For each subject, the average of the amplitude of the nine electrodes is calculated and represents the synthetic parameter for amplitude N400.This is a quantitative parameter. Values will be compared between the two groups of subjects (G1-SCZ and G2-TAB).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subject showing no severe or progressive somatic pathology, including neurological pathology (head injury, epilepsy, tumor process or multiple sclerosis causing EEG changes incompatible with the observation of ERP characteristics of both psychiatric disorders explored)

  • Subject showing a diagnosis of schizophrenia or a diagnosis of bipolar affective disorders, as defined in the DSM IV-TR, in time of inclusion.

  • Subject showing no disorder related to the use of a substance according to DSM IV-TR during the last 12 months prior to enrollment.

  • Subject not showing another psychiatric disorder according to DSM IV-TR (axis 1 disorders), including schizoaffective disorder or a delusional disorder (not schizophrenic).

Exclusion Criteria:
  • Subject unable to give informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hôpitaux de Marseille Marseille France 13005

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle DESALBRES, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT02329119
Other Study ID Numbers:
  • 2014-07
  • RCAPHM14_0077
First Posted:
Dec 31, 2014
Last Update Posted:
Aug 21, 2015
Last Verified:
Aug 1, 2015
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2015