Gluten Free Diet in People With Schizophrenia: A Pilot Study
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia, Endocrine |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/1/2014 |
| Start Date: | June 2008 |
| Contact: | Ann Kearns, BS |
| Email: | akearns@mprc.umaryland.edu |
| Phone: | 410-402-6854 |
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;
1. Celiac disease (positive tTG antibody); and
2. Positive assay on Antigliadin antibodies
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;
1. Celiac disease (positive tTG antibody); and
2. Positive assay on Antigliadin antibodies
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.
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