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NCT01558570 Clinical Trial

Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

Schizophrenia Clinical Trial

Official title:
Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01558570
Other study ID # HP-00049310
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2011
Est. completion date February 2012

Study information
Verified date September 2019
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood Draw
One time blood draw

Locations
Country Name City State
United States Maryland Psychiatric Research Center Catonsville Maryland

Sponsors (2)
Lead Sponsor Collaborator
University of Maryland, Baltimore University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Zonulin concentration in serum (ng/mg) 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
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