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

NCT00894296 | Unknown DMC

• 1 other identifier: 0027-08-SHA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

MEG; schizophrenia; negative symptoms

Outcome Measures

Primary Outcomes (1)

• Primary outcome measures will include continuous and ERP (Event Related Potential) MEG (Magnetoencephalograph) data

  four months

Study Arms (2)

1

schizophrenia patients

2

healthy control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

schizophrenia patients and healthy subjects between the ages 18-65

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shalvata Mental Health Center: lead
• Bar-Ilan University, Israel: collaborator

Study Sites (1)

Bar-Ilan University

Givat Shmuel, Israel

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Liron Rabani, MA

CONTACT

972-97478644

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 6, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

IL (1)