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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bar-Ilan University, Israel
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00894296
First received: May 5, 2009
Last updated: January 4, 2012
Last verified: January 2012

May 5, 2009
January 4, 2012
March 2009
January 2013   (final data collection date for primary outcome measure)
Primary outcome measures will include continuous and ERP (Event Related Potential) MEG (Magnetoencephalograph) data [ Time Frame: four months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00894296 on ClinicalTrials.gov Archive Site
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Magnetoencephalographic (MEG) Correlates of Negative Symptoms in Patients Suffering From Schizophrenia and Their Influence by Add-on Treatments
Magnetoencephalographic (MEG) Correlates of Negative Symptoms in Patients Suffering From Schizophrenia and Their Influence by Add-on Treatments

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

schizophrenia patients and healthy subjects between the ages 18-65

Schizophrenia
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  • 1
    schizophrenia patients
  • 2
    healthy control
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Study Group (Schizophrenia Patients) 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)

Inclusion criteria:

  • 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
Both
18 Years to 65 Years
Yes
Contact: Liron Rabani, MA 972-97478644 ext 09
Israel
 
NCT00894296
0027-08-SHA
Yes
Shalvata Mental Health Center
Shalvata Mental Health Center
Bar-Ilan University, Israel
Not Provided
Shalvata Mental Health Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP