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Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)

Primary Purpose

Schizophrenia, Gluten Sensitivity, Schizo Affective Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gluten Flour in Protein Shake
Rice Flour in Protein Shake
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. DSM-IV/DSM 5 diagnosis of schizophrenia or schizoaffective disorder
  2. Positive for antibodies to gliadin (IgG > 20 U)
  3. SANS total score ≥ 20 and the affective flattening or alogia global item ≥ 3
  4. Age 18- 64 years
  5. Same antipsychotic for at least 4 weeks
  6. Ability to consent determined by a score of 10 or greater on the Evaluation to Sign Consent.

Exclusion Criteria:

  1. Persons already on gluten free diets
  2. Positivity to tissue transglutaminase (tTg) antibodies or known history of Celiac Disease
  3. Pregnant or lactating females
  4. Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
  5. Meets DSM-5 criteria for alcohol or substance use disorder (other than nicotine) within the last month

  6. Gluten ataxia, as measured by the Brief Ataxia Rating Scale

    Additional exclusion for those participating in optional imaging component:

  7. Non-removable ferromagnetic metal on or within the body
  8. Current claustrophobia
  9. Inability to lie supine for 1.5 hours

Sites / Locations

  • Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gluten

Placebo

Arm Description

30 grams of gluten flour daily in protein shake

30 grams of rice flour daily in protein shake

Outcomes

Primary Outcome Measures

Negative symptom change as defined by difference in Scale for the Assessment of Negative Symptoms (SANS) score
This will be measured by the difference in Scale for the Assessment of Negative Symptoms (SANS) score from baseline to week 5.

Secondary Outcome Measures

Change in cognitive function as measured by change in MATRICS Consensus Cognitive Battery (MCCB)
This will be measured by the difference in MATRICS Consensus Cognitive Battery (MCCB) scores from baseline to week 5

Full Information

First Posted
June 7, 2017
Last Updated
October 26, 2022
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03183609
Brief Title
Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)
Official Title
Confirmatory Double-Blind Placebo-Controlled Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study purpose is to conduct a confirmatory double-blind randomized controlled trial in an inpatient setting of the effects of a tightly controlled gluten-free diet (GFD) to improve negative symptoms in people with schizophrenia or schizoaffective disorder who have antibodies to gliadin (AGA IgG). As part of the project investigators will also confirm outcomes such as cognitive symptoms, changes in peripheral and central inflammation as well as gut/blood brain barrier permeability.
Detailed Description
This study is a randomized double blind clinical trial being funded by NIMH. Investigators will need to enroll 40 cases with AGA IgG positivity in order to present a powered and convincing result about the efficacy of gluten withdrawal in the subpopulation of persons with schizophrenia with elevated AGA IgG levels. Investigators will recruit a minimum 50 to ensure they are well powered without question, and to account for dropouts. Investigators will use a battery of measures of peripheral and central inflammation as well as gut permeability at baseline and endpoint to confirm the relationship of these outcomes to changes in AGA IgG and symptom changes in the clinical trial. Investigators will test negative symptoms as a primary outcome but will test changes in other symptom domains such as positive symptoms. After the completion of the 5 week confirmatory study, investigators will discharge participants and follow them for 8 weeks in their own environment to test the maintenance of the effect following the stringent GFD, and provide education on gluten free shopping, cooking and eating.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Gluten Sensitivity, Schizo Affective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double blind trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gluten
Arm Type
Active Comparator
Arm Description
30 grams of gluten flour daily in protein shake
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
30 grams of rice flour daily in protein shake
Intervention Type
Other
Intervention Name(s)
Gluten Flour in Protein Shake
Intervention Description
15 Grams Gluten Flour BID
Intervention Type
Other
Intervention Name(s)
Rice Flour in Protein Shake
Intervention Description
15 Grams Rice Flour BID
Primary Outcome Measure Information:
Title
Negative symptom change as defined by difference in Scale for the Assessment of Negative Symptoms (SANS) score
Description
This will be measured by the difference in Scale for the Assessment of Negative Symptoms (SANS) score from baseline to week 5.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Change in cognitive function as measured by change in MATRICS Consensus Cognitive Battery (MCCB)
Description
This will be measured by the difference in MATRICS Consensus Cognitive Battery (MCCB) scores from baseline to week 5
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV/DSM 5 diagnosis of schizophrenia or schizoaffective disorder Positive for antibodies to gliadin (IgG > 20 U) SANS total score ≥ 20 and the affective flattening or alogia global item ≥ 3 Age 18- 64 years Same antipsychotic for at least 4 weeks Ability to consent determined by a score of 10 or greater on the Evaluation to Sign Consent. Exclusion Criteria: Persons already on gluten free diets Positivity to tissue transglutaminase (tTg) antibodies or known history of Celiac Disease Pregnant or lactating females Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol Meets DSM-5 criteria for alcohol or substance use disorder (other than nicotine) within the last month Gluten ataxia, as measured by the Brief Ataxia Rating Scale Additional exclusion for those participating in optional imaging component: Non-removable ferromagnetic metal on or within the body Current claustrophobia Inability to lie supine for 1.5 hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Keanrs, MS
Phone
410-402-6854
Email
akearns@mprc.umaryland.edu
Facility Information:
Facility Name
Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AnnMarie Kearns, BS
Phone
410-402-6854
Email
akearns@mprc.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Feldman, MSW
Phone
410-402-6885
Email
sfeldman@mprc.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Deanna L Kelly, Pharm.D., BCPP

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.mprc.umaryland.edu
Description
Maryland Psychiatric Research Center

Learn more about this trial

Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)

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