Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

NCT01558570 | Completed

• 1 other identifier: HP-00049310
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Celiac Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Schizophrenia

Procedure: Blood Draw

Interventions

Blood Draw PROCEDURE

One time blood draw

Schizophrenia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• DSM-IV Diagnosis of Schizophrenia or Schizoaffective Disorder
• Male or females between ages of 18 to 75 years

You may not qualify if:

• Score below 10/12 on the Evaluation to Sign Consent (ESC)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Maryland, College Park: collaborator

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

Related Links

• Maryland Psychiatric Research Center

Biospecimen

Retention: SAMPLES WITH DNA

Laboratory Measures: 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.

MeSH Terms

Conditions

Schizophrenia; Celiac Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Deanna L. Kelly, Pharm.D., BCPP

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deanna L. Kelly, Pharm.D., BCPP

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: March 20, 2012
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

US (1)