Gluten Free Diet in People With Schizophrenia: A Pilot Study
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Purpose
Background: Celiac disease is an immune-mediated reaction to gluten, presenting with diarrhea, weight loss, abdominal complaints and a range of less common associated neurologic and psychiatric symptoms. Evidence of a link between schizophrenia and celiac disease dates back to 1961. Recent evidence shows that 5.5% (age adjusted) of persons with schizophrenia participating in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study had a level of antibodies to tTG that is consistent with a diagnosis of celiac disease (compared to 1.1% of the comparison sample). An unexpected finding was that 23.4% (age adjusted) of the CATIE sample had antibodies to gliadin (compared to 2.9% of the comparison sample). It is hypothesized that a gluten free diet in people with schizophrenia who have Celiac disease or gluten sensitivity will have improvement in symptoms and quality of life.
Objectives: The aim of this proposed pilot study is to establish the feasibility of a initiating and maintaining a Gluten-free diet in these two groups. For this study The investigators will identify 8 individuals who have positive assays to tTG antibodies and confirmed celiac disease (N=4), or positive assays for anti-gliadin antibodies (N=4). The investigators plan to consent at least 2 subjects from each group and ask them to participate in a two-week open label treatment of a gluten free diet. The groups are;
- Celiac disease (positive tTG antibody); and
- Positive assay on Antigliadin antibodies
| Condition | Intervention |
|---|---|
|
Gluten Sensitivity Celiac Disease |
Other: Gluten Free Diet |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Gluten Free Diet in People With Schizophrenia: A Pilot Study |
- Change in symptoms from baseline to end of study [ Time Frame: Baseline and 2 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
-
Other: Gluten Free Diet
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects will be of either gender and of any race, with an age range of 18 55.
- Subjects will meet DSM-IV (APA, 1994) criteria for either schizophrenia or schizoaffective disorder. A best estimate diagnostic approach will be utilized in which information from the Structured Clinical Interview for DSM-IV (First et al, 1997) is supplemented by information from family informants, previous psychiatrists, and medical records to generate a diagnosis.
- Subjects will be required to have celiac disease (positive tTG antibody) or have gluten sensitivity (positive or AGA antibodies).
- Must be clinically stable and on the same antipsychotic for at least two months with an unchanged dose for the prior four weeks.
- Participants must complete the Evaluation to Sign Consent with a score of 10/12 or higher.
Exclusion Criteria:
- Pregnant or lactating women will be excluded. Pregnancy will be determined by pregnancy test. Lactating will be determined by participant report.
Contacts and Locations| Contact: Ann Kearns, BS | 410-402-6854 | akearns@mprc.umaryland.edu |
| United States, Maryland | |
| Maryland Psychiatric Research Center | Recruiting |
| Catonsville, Maryland, United States, 21228 | |
| Contact: Ann Kearns, BS 410-402-6854 akearns@mprc.umaryland.edu | |
| Principal Investigator: | Deanna L Kelly, Pharm.D., BCPP | Principal Investigator |
More Information
No publications provided
| Responsible Party: | MPRC, Deanna L. Kelly, Pharm.D., BCPP, University of Maryland |
| ClinicalTrials.gov Identifier: | NCT01558557 History of Changes |
| Other Study ID Numbers: | HP-00041292 |
| Study First Received: | March 15, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Celiac Disease Schizophrenia Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Metabolic Diseases Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013