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

This study is currently recruiting participants.
Verified January 2012 by Shalvata Mental Health Center
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
History of Changes
  Purpose

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


Condition Phase
Schizophrenia
 Phase 0

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Magnetoencephalographic (MEG) Correlates of Negative Symptoms in Patients Suffering From Schizophrenia and Their Influence by Add-on Treatments

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Primary outcome measures will include continuous and ERP (Event Related Potential) MEG (Magnetoencephalograph) data [ Time Frame: four months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
schizophrenia patients
2
healthy control

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

schizophrenia patients and healthy subjects between the ages 18-65

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894296

Contacts
Contact: Liron Rabani, MA 972-97478644 ext 09

Locations
Israel
Bar-Ilan University Recruiting
Givat Shmuel, Israel
Contact: Liron Rabani, MA     7478644 ext 09        
Principal Investigator: Liron Rabany, MA            
Sponsors and Collaborators
Shalvata Mental Health Center
Bar-Ilan University, Israel
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT00894296     History of Changes
Other Study ID Numbers: 0027-08-SHA
Study First Received: May 5, 2009
Last Updated: January 4, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
MEG
schizophrenia
negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Stress, Psychological
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013