Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 64 Years|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Maryland, Baltimore|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Schizophrenia, Gluten Sensitivity, Schizo Affective Disorder|
|Study Website:||View Trial Website|
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.
Active Comparator: Gluten
30 grams of gluten flour daily in protein shake
Placebo Comparator: Placebo
30 grams of rice flour daily in protein shake
Other: - Gluten Flour in Protein Shake
15 Grams Gluten Flour BID
Other: - Rice Flour in Protein Shake
15 Grams Rice Flour BID
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.