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)
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 8/3/2018 |
| Start Date: | July 10, 2017 |
| End Date: | July 30, 2025 |
| Contact: | Ann Keanrs, MS |
| Email: | akearns@mprc.umaryland.edu |
| Phone: | 410-402-6854 |
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)
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.
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.
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.
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.
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
We found this trial at
1
site
55 Wade Avenue
Catonsville, Maryland 21228
Catonsville, Maryland 21228
Principal Investigator: Deanna L Kelly, Pharm.D., BCPP
Phone: 410-402-6854
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