Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01558570
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : March 20, 2012
Information provided by (Responsible Party):
MPRC, University of Maryland

Brief Summary:
The purpose of this protocol is to collect serum zonulin levels in people with schizophrenia. This one time visit will collect zonulin levels, antibodies to gliadin (tissue transglutaminase and antigliadin antibodies) and other information that may relate to increased intracellular tight junction permeability as it related to the immune and stress system and the immune association with kynurenic acid pathway 50. Data will be collected for use in future grant applications and published reports.

Condition or disease Intervention/treatment
Schizophrenia Celiac Disease Procedure: Blood Draw

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin
Study Start Date : July 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
Schizophrenia Procedure: Blood Draw
One time blood draw

Primary Outcome Measures :
  1. Zonulin concentration in serum (ng/mg) [ Time Frame: 1 day ]
    Participants will undergo a one-time blood draw in order to test for zonulin concentration in serum (ng/mg) and these results will be compared to normative data to screen for elevations. The sample size for this pilot study was estimated based on the known prevalence of Celiac disease in schizophrenia, a disease known to have elevated zonulin levels.

Biospecimen Retention:   Samples With DNA

Laboratory Measures:

Zonulin and gliadin antibodies will be sent to the lab of Dr. Alessio Fasano for assay.

Genetic and Biochemical analysis will be sent for analysis and storage of blood sample at the Maryland Psychiatric Research Center Neurogenetics laboratory under the direction of Dr. Ikwunga Wonodi. Analysis will include kynurenic acid metabolites, inflammatory markers from Peripheral Blood Mononuclear Cells (PBMC) and future genetic analysis including but not limited to human leukocyte antigen (HLA) haplotypes (DQ2 and DQ8).

Cytokines will be analyzed by the Cytokine Core Laboratory at the University of Maryland using Luminex Technology.

Other standard laboratories will be done by Lab Corp or other contract laboratory.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with schizophrenia will be recruited by MPRC through their patient recruiting network including the Treatment Research Program and the Outpatient Research Program and affiliated sites. Patient with schizophrenia may also be recruited through the NIDA screening protocol process. (UMB approved IRB protocol HP-00043664)

Inclusion Criteria:

  • DSM-IV Diagnosis of Schizophrenia or Schizoaffective Disorder
  • Male or females between ages of 18 to 75 years

Exclusion Criteria:

  • Score below 10/12 on the Evaluation to Sign Consent (ESC)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01558570

United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Principal Investigator: Deanna L. Kelly, Pharm.D., BCPP University of Maryland

Additional Information:
Responsible Party: MPRC, Deanna L. Kelly, Pharm.D., BCPP, University of Maryland Identifier: NCT01558570     History of Changes
Other Study ID Numbers: HP-00049310
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Celiac Disease
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases