Gluten Free Diet in People With Schizophrenia: A Pilot Study

Celiac Disease Clinical Trial

Official title:

Gluten Free Diet in People With Schizophrenia: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558557
• Other study ID #: HP-00041292
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: January 2014

Study information

• Verified date: September 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease
• Gluten Sensitivity
• Schizophrenia

Intervention

Other:
• Gluten Free Diet
Participants will be given a Gluten Free Diet for 2 weeks

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center	Catonsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in symptoms from baseline to end of study		Baseline and 2 Weeks