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Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT01558570
First received: September 12, 2011
Last updated: March 17, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Schizophrenia
Celiac Disease
 Procedure: Blood Draw

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Zonulin concentration in serum (ng/mg) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Schizophrenia Procedure: Blood Draw
One time blood draw

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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)

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558570

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

Additional Information:
Maryland Psychiatric Research Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: MPRC, Deanna L. Kelly, Pharm.D., BCPP, University of Maryland
ClinicalTrials.gov Identifier: NCT01558570     History of Changes
Other Study ID Numbers: HP-00049310
Study First Received: September 12, 2011
Last Updated: March 17, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013