NCT01396850

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
Last Updated

July 19, 2011

Status Verified

July 1, 2011

First QC Date

July 17, 2011

Last Update Submit

July 18, 2011

Conditions

Keywords

Psychotic Patients

Study Arms (4)

Psychotic Group

Anxiety

Depressed

Control Group

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \. Drug or alcohol abuse. 3. Patients that will need anesthesia in order to perform the MR study (not including patients who are already ventilated).
  • \. Patients with metal foreign body, or other contraindication to MR (according to the MR regulations).
  • \. Tourists or foreign residents that long terms follow up is not feasible for them.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2011

First Posted

July 19, 2011

Last Updated

July 19, 2011

Record last verified: 2011-07