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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)

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ClinicalTrials.gov Identifier: NCT03183609
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Deanna Kelly, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Gluten Sensitivity Schizo Affective Disorder Other: Gluten Flour in Protein Shake Other: Rice Flour in Protein Shake Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double blind trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Gluten
30 grams of gluten flour daily in protein shake
Other: Gluten Flour in Protein Shake
15 Grams Gluten Flour BID

Placebo Comparator: Placebo
30 grams of rice flour daily in protein shake
Other: Rice Flour in Protein Shake
15 Grams Rice Flour BID




Primary Outcome Measures :
  1. Negative symptom change as defined by difference in Scale for the Assessment of Negative Symptoms (SANS) score [ Time Frame: 5 weeks ]
    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 :
  1. Change in cognitive function as measured by change in MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: 5 weeks ]
    This will be measured by the difference in MATRICS Consensus Cognitive Battery (MCCB) scores from baseline to week 5



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183609


Contacts
Contact: Ann Keanrs, MS 410-402-6854 akearns@mprc.umaryland.edu

Locations
United States, Maryland
Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP) Recruiting
Catonsville, Maryland, United States, 21228
Contact: AnnMarie Kearns, BS    410-402-6854    akearns@mprc.umaryland.edu   
Contact: Stephanie Feldman, MSW    410-402-6885    sfeldman@mprc.umaryland.edu   
Principal Investigator: Deanna L Kelly, Pharm.D., BCPP         
Sponsors and Collaborators
University of Maryland

Additional Information:
Responsible Party: Deanna Kelly, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT03183609     History of Changes
Other Study ID Numbers: HP-00075175
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Schizophrenia
Mood Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antibodies
Immunologic Factors
Physiological Effects of Drugs