SchizophreniaNCT03183609
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)
A study testing Gluten Flour in Protein Shake and Rice Flour in Protein Shake in people with Schizophrenia and Gluten Sensitivity, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia, Gluten Sensitivity, Schizo Affective Disorder
- What is being tested?
- Gluten Flour in Protein Shake and Rice Flour in Protein Shake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2017to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
- Meets DSM-5 criteria for alcohol or substance use disorder (other than nicotine) within the last month
- Gluten ataxia, as measured by the Brief Ataxia Rating Scale
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)
Catonsville, Maryland, 21228
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Gluten Sensitivity, Schizo Affective Disorder
- Being tested
- Gluten Flour in Protein Shake, Rice Flour in Protein Shake
- Medical subject headings
- Schizophrenia, Celiac Disease, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten Flour in Protein ShakeOther
15 Grams Gluten Flour BID
Rice Flour in Protein ShakeOther
15 Grams Rice Flour BID
| Study group | Role | What they receive |
|---|---|---|
| Gluten | Active comparator | 30 grams of gluten flour daily in protein shake Receives: Other: Gluten Flour in Protein Shake |
| Placebo | Placebo comparator | 30 grams of rice flour daily in protein shake Receives: Other: Rice Flour in Protein Shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative symptom change as defined by difference in Clinical Assessment of Negative Symptoms -Motivation and Pleasure scale (CAINS-MAP)
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.
Measured: 5 weeks
Secondary outcomes (1)
Change in cognitive function as measured by change in MATRICS Consensus Cognitive Battery (MCCB)
This will be measured by the difference in MATRICS Consensus Cognitive Battery (MCCB) scores from baseline to week 5
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start10 Jul 2017
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deanna Kelly, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183609
- Sponsor's protocol ID
- HP-00075175
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2017
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daniels EC, Eaton WW, Cihakova D, Talor MV, Lemke H, Mo C, Chen S, Notarangelo FM, Rodriguez KM, Kelly DL. The relationship of peripheral inflammation with antibodies to gliadin (AGA IgG) in persons with schizophrenia. Schizophr Res. 2023 Jun;256:50-51. doi: 10.1016/j.schres.2023.02.027. Epub 2023 May 5. No abstract available.
PubMed 37150147
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03183609
- Acronym / sponsor ID
- HP-00075175
- Conditions
- Schizophrenia, Gluten Sensitivity, Schizo Affective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blind trial
| Arm | Type | Receives |
|---|---|---|
| Gluten | Active comparator | Other: Gluten Flour in Protein Shake30 grams of gluten flour daily in protein shake |
| Placebo | Placebo comparator | Other: Rice Flour in Protein Shake30 grams of rice flour daily in protein shake |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Meets DSM-5 criteria for alcohol or substance use disorder (other than nicotine) within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten Flour in Protein Shake15 Grams Gluten Flour BID | Other | Gluten |
| Rice Flour in Protein Shake15 Grams Rice Flour BID | Other | Placebo |
Primary outcome
Negative symptom change as defined by difference in Clinical Assessment of Negative Symptoms -Motivation and Pleasure scale (CAINS-MAP)
Time frame: 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.
1 secondary outcome
Change in cognitive function as measured by change in MATRICS Consensus Cognitive Battery (MCCB)
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 37150147Daniels EC, Eaton WW, Cihakova D, Talor MV, Lemke H, Mo C, Chen S, Notarangelo FM, Rodriguez KM, Kelly DL. The relationship of peripheral inflammation with antibodies to gliadin (AGA IgG) in persons with schizophrenia. Schizophr Res. 2023 Jun;256:50-51. doi: 10.1016/j.schres.2023.02.027. Epub 2023 May 5. No abstract available.
- Maryland Psychiatric Research CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten Flour in Protein Shake and Rice Flour in Protein Shake in people with Schizophrenia and Gluten Sensitivity, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative symptom change as defined by difference in Clinical Assessment of Negative Symptoms -Motivation and Pleasure scale (CAINS-MAP) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03183609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.