Intracellular Tight Junction Permeability in Schizophreni... | NCT01558570

Studies
Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

NCT01558570

Sponsor

University of Maryland, Baltimore

Status

Completed

Last Update Posted

Sep 26, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Schizophrenia
Celiac Disease

Interventions

Blood Draw

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Sep 12, 2011

First Submission Date that Met QC Criteria

Mar 17, 2012

First Posted Date

Mar 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2019

Last Update Posted Date

Sep 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

MPRC, Deanna L. Kelly, Pharm.D., BCPP, University of Maryland, BaltimorePrincipal Investigator

Lead Sponsor

University of Maryland, BaltimoreOTHER

Collaborators

Name	Class
University of Maryland, College Park	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Schizophrenia			Procedure: Blood Draw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Draw	Procedure	One time blood draw	Schizophrenia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deanna L. Kelly, Pharm.D., BCPP	University of Maryland, College Park	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maryland Psychiatric Research Center		Catonsville	Maryland	21228	United States

Label	URL
Maryland Psychiatric Research Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D002446	Celiac Disease

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.