Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01558570

Enrollment

100

Registered

2012-03-20

Start date

2011-07-31

Completion date

2012-02-29

Last updated

2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease, Schizophrenia

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.

Interventions

PROCEDUREBlood Draw

One time blood draw

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026