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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00894296
• Other study ID #: 0027-08-SHA
• Status: Recruiting
• Phase: Phase 0
• First received: May 5, 2009
• Last updated: January 4, 2012
• Start date: March 2009
• Est. completion date: January 2013

Study information

• Verified date: January 2012
• Source: Shalvata Mental Health Center
• Contact: Liron Rabani, MA
• Phone: 972-97478644
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Israel	Bar-Ilan University	Givat Shmuel

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measures will include continuous and ERP (Event Related Potential) MEG (Magnetoencephalograph) data		four months	No