Psychiatric Disorders and Electrophysiological Markers (ERPs-PSY)
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|ClinicalTrials.gov Identifier: NCT02329119|
Recruitment Status : Unknown
Verified August 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Not yet recruiting
First Posted : December 31, 2014
Last Update Posted : August 21, 2015
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|
|Schizophrenia||Other: electrophysiological recordings||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Psychiatric Disorders and Electrophysiological Markers|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2019|
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
- amplitude (in µV) of negativity observed the highest between 250 and 500 ms for the N400 component of Event Related Potentials (ERP) [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329119
|Contact: Michel CERMOLACCE, Drfirstname.lastname@example.org|
|Assistance Publique Hôpitaux de Marseille|
|Marseille, France, 13005|
|Contact: Michel Cermolacce email@example.com|
|Study Director:||Urielle DESALBRES||Assistance Publique Hopitaux De Marseille|