Magnetoencephalographic (MEG) Correlates of Negative Symptoms in Patients Suffering From Schizophrenia and Their Influence by Add-on Treatments

NCT ID: NCT00894296

Last Updated: 2012-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-01-31

Brief Summary

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The objective of the suggested study is to identify changes in MEG correlates caused by the add-on treatment with the changes in negative symptoms of schizophrenia by comparing the change in the MEG correlates of the subjects before and during usage of new add on treatments for negative symptoms.

The investigators hypothesize that the gravity of negative symptoms will correlate with a trend towards more aberrant electroencephalographic correlates mainly in continuous parameters, with an emphasis on alpha and delta bands

Detailed Description

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There is a paucity of information regarding electrophysiological correlates of negative symptoms in patients suffering from schizophrenia. The proposed study is set out to compare the MEG correlates of negative symptoms in patients suffering from schizophrenia to those of healthy controls in terms of both relevant ERP components and quantified (continuous) MEG.

The presented study will include two parts: Part A will explore the electrophisological correlates of negative symptoms in patients suffering from schizophrenia using MEG. The study will do so by comparing the electrophisological correlates of schizophrenia patients suffering from negative symptoms and stable on psychiatric treatment to those of healthy controls. In the second part of the study data from part A of patients that have started new add-on treatments for negative symptoms will be compared to parallel data acquired after stabilization on the new treatment.

Conditions

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Schizophrenia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

schizophrenia patients

No interventions assigned to this group

2

healthy control

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria.
* Right hand dominant.
* Scores in PANSS negative questionnaire above 21 and positive symptom less than 24.
* Gave informed consent for participation in the study.
* Stable on the same antipsychotic medication for at least a month prior to entering the study Control Group (healthy Subjects)


* Healthy man and woman
* Ages 18-65
* Right handed

Exclusion Criteria

* Study Group (Schizophrenia Patients) (To prevent MEG artifacts by non relevant electric interference or brain conditions)
* History of epilepsy, seizure, or hot spasm, sever head injuries.
* History of metal in the head (outside the mouth space).
* History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
* History of migraines.
* History of drug or alcohol abuse during the last year. Inability to achieve satisfying level of communication with the subject Control Group (healthy Subjects)
* History of psychiatric diagnosis
* Drug or alcohol addiction in the year prior to the study
* History of epilepsy, seizure, or hot spasm.
* History of head injuries.
* History of metal in the head (outside the mouth space).
* History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
* History of migraines.
* Use of psychotropic medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bar-Ilan University, Israel

OTHER

Sponsor Role collaborator

Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bar-Ilan University

Givat Shmuel, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Liron Rabani, MA

Role: CONTACT

972-97478644 ext. 09

Facility Contacts

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Liron Rabani, MA

Role: primary

7478644 ext. 09

Other Identifiers

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0027-08-SHA

Identifier Type: -

Identifier Source: org_study_id

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