Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin
|ClinicalTrials.gov Identifier: NCT01558570|
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : March 20, 2012
|Condition or disease||Intervention/treatment|
|Schizophrenia Celiac Disease||Procedure: Blood Draw|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Procedure: Blood Draw
One time blood draw
- 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.
Biospecimen Retention: Samples With DNA
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558570
|United States, Maryland|
|Maryland Psychiatric Research Center|
|Catonsville, Maryland, United States, 21228|
|Principal Investigator:||Deanna L. Kelly, Pharm.D., BCPP||University of Maryland|