NCT03183609Completed
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)
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)
Source: ClinicalTrials.gov · Last updated 12 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 7 Jun 2017
- Start date
- 10 Jul 2017
- Primary completion date
- 30 Mar 2024
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Schizophrenia
- NCT number
- NCT03183609
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 10 Jul 2017 to the primary completion date, 30 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Positivity to tissue transglutaminase (tTg) antibodies or known history of Celiac Disease
- 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
- Meets DSM-5 criteria for alcohol or substance use disorder (other than nicotine) within the last month
Other
- Persons already on gluten free diets
- Pregnant or lactating females
- Gluten ataxia, as measured by the Brief Ataxia Rating Scale
- Additional exclusion for those participating in optional imaging component:
- Non-removable ferromagnetic metal on or within the body
- Current claustrophobia
- Inability to lie supine for 1.5 hours
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP) Coordinator of this site? Confirm its status | Catonsville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.