Measurments Of BBB Breakdown In The Pathogenesis Of Psychiatric Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01396850
First received: July 17, 2011
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

BBB dysfunction has been indicated in some groups of schizophrenia patients by measuring increased albumin and immunoglobulin (IgG) cerebrospinal fluid (CSF) levels. Most of the authors described a raised protein level in 5-20% of the schizophrenic patients (Muller & Ackenheil, 1995). Increased S100B levels were demonstrated in the serum of patients suffering from schizophrenia as well as depression, and this may reflect increased BBB permeability. Furthermore, this increase remains in those patients who develop a residual state with relevant negative symptoms, whereas S100B levels normalize in recovering patients (Shalev, Serlin & Friedman, 2009). CSF albumin and CSF IgG values correlate significantly with some of the SANS (Scale for the Assessment of Negative Symptoms) subscales and the SANS total score, this shows the correlation between BBB permeability and behavioral changes. It is important to say that although negative symptoms are often signs of chronicity of the disease, the abnormal CSF findings in Muller's experiment (1995) are not related to the duration of the disease, because the patients were quite young and the duration of the disease was less than 3 years.

The investigators hypothesize that a primary vascular pathology, which leads to BBB breakdown, will result a leakage of serum-derived vascular components in to the brain tissue and may cause brain dysfunction such as disturbed thinking processes, mood and behavior, as we can see in psychiatric patients.


Condition
Psychosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: THE ROLE OF BBB BREAKDOWN IN THE PATHOGENESIS OF PSYCHIATRIC DISORDERS

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Estimated Enrollment: 120
Groups/Cohorts
Psychotic Group
Anxiety
Depressed
Control Group

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Psychotic, affective disorders or anxiety disorders patients admitted to Soroka Medical Center from the psychiatric hospital or self admissions to the Psychiatric department.

Criteria

Inclusion Criteria: Psychotic, affective disorders or anxiety disorders patients admitted to Soroka Medical Center from the psychiatric hospital or self admissions to the Psychiatric department.

Patients were evaluated by study psychiatrist. Signed informed consent by the patient or his legal custodian. Subjects Age 16-65 years.

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Exclusion Criteria:1. Patients with neurological disease, including epilepsy, ischemic stroke, multiple sclerosis, Parkinson's disease, etc.

2. Drug or alcohol abuse. 3. Patients that will need anesthesia in order to perform the MR study (not including patients who are already ventilated).

4. Patients with metal foreign body, or other contraindication to MR (according to the MR regulations).

5. Tourists or foreign residents that long terms follow up is not feasible for them.

6. Patients with renal failure / any other kind of kidney problems. 7. Pregnant women. 8. Patient with brain-injury. 9. Suicidal patients/patients with high risk for suicide/violent patients or patients that their condition might deteriorate due to participation in this study.

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  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01396850     History of Changes
Other Study ID Numbers: sor497310ctil
Study First Received: July 17, 2011
Last Updated: July 18, 2011
Health Authority: Israel: Clalit Health Services

Keywords provided by Soroka University Medical Center:
Psychotic Patients

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on October 20, 2014