Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

Completed

• Conditions: Celiac Disease; Schizophrenia
• Interventions: Procedure: Blood Draw

• Registration Number: NCT01558570
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-12
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted QC: 2012-03-17
• Study First Posted: 2012-03-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Schizophrenia	Blood Draw	-

Primary Outcome Measures

Name	Time	Method
Zonulin concentration in serum (ng/mg)	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.

Trial Locations

Locations (1)

Maryland Psychiatric Research Center; 🇺🇸 Catonsville, Maryland, United States