Psychiatric Disorders and Electrophysiological Markers

NCT ID: NCT02329119

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-02-28

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

G1-SCZ

patients with schizophrenia as defined in DSM IV-TR

Group Type: EXPERIMENTAL

electrophysiological recordings

Intervention Type: OTHER

G2-TAB

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

Group Type: ACTIVE_COMPARATOR

electrophysiological recordings

Intervention Type: OTHER

Interventions

electrophysiological recordings

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

Central Contacts

Michel CERMOLACCE, Dr

Role: CONTACT

michel.cermolacce@ap-hm.fr

Facility Contacts

Michel Cermolacce

Role: primary

michel.cermolacce@ap-hm.fr

Other Identifiers

RCAPHM14_0077

Identifier Type: REGISTRY

Identifier Source: secondary_id

2014-07

Identifier Type: -

Identifier Source: org_study_id