Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

September 24, 2019 updated by: MPRC, University of Maryland, Baltimore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Catonsville, Maryland, United States, 21228
        • Maryland Psychiatric Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

University of Maryland, College Park

Investigators

  • Principal Investigator: Deanna L. Kelly, Pharm.D., BCPP, University of Maryland, College Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

March 17, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00049310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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