Gluten Sensitivity, Schizo Affective Disorder, Schizophrenia
Conditions
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.
Interventions
OTHERGluten Flour in Protein Shake
15 Grams Gluten Flour BID
OTHERRice Flour in Protein Shake
15 Grams Rice Flour BID
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized double blind trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative symptom change as defined by difference in Clinical Assessment of Negative Symptoms -Motivation and Pleasure scale (CAINS-MAP) | 5 weeks | This will be measured by the difference in Clinical Assessment of Negative Symptoms -Motivation and Pleasure scale CAINS-MAP) score from baseline to week 5, with a lower score yielding a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function as measured by change in MATRICS Consensus Cognitive Battery (MCCB) | 5 weeks | This will be measured by the difference in MATRICS Consensus Cognitive Battery (MCCB) scores from baseline to week 5 |
Countries
United States
Outcome results
None listed