Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who… (NCT03183609) | Clinical Trial Compass
CompletedNot Applicable
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)
United States40 participantsStarted 2017-07-10
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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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
What they're measuring
1
Negative symptom change as defined by difference in Clinical Assessment of Negative Symptoms -Motivation and Pleasure scale (CAINS-MAP)