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Trial record 8 of 36 for:    Not yet recruiting Studies | psychiatric

Psychiatric Disorders and Electrophysiological Markers (ERPs-PSY)

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ClinicalTrials.gov Identifier: NCT02329119
Recruitment Status : Not yet recruiting
First Posted : December 31, 2014
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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
Schizophrenia Other: electrophysiological recordings Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


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



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) [ 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Michel CERMOLACCE, Dr michel.cermolacce@ap-hm.fr

Locations
France
Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13005
Contact: Michel Cermolacce       michel.cermolacce@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Urielle DESALBRES Assistance Publique Hopitaux De Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02329119     History of Changes
Other Study ID Numbers: 2014-07
RCAPHM14_0077 ( Registry Identifier: APHM )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Problem Behavior
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms