Gluten Free Diet in People With Schizophrenia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in symptoms from baseline to end of study
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be of either gender and of any race, with an age range of 18
- •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.
排除标准
- •Pregnant or lactating women will be excluded. Pregnancy will be determined by pregnancy test. Lactating will be determined by participant report.
研究组 & 干预措施
Gluten Free Diet
干预措施: Gluten Free Diet (Other)
结局指标
主要结局
Change in symptoms from baseline to end of study
时间窗: Baseline and 2 Weeks
次要结局
未报告次要终点
研究者
MPRC
Deanna L. Kelly, Pharm.D., BCPP
University of Maryland, Baltimore