Gluten Free Diet in People With Schizophrenia: A Pilot Study
Primary Purpose
Gluten Sensitivity, Celiac Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gluten Free Diet
Sponsored by
About this trial
This is an interventional treatment trial for Gluten Sensitivity
Eligibility Criteria
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.
Sites / Locations
- Maryland Psychiatric Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gluten Free Diet
Arm Description
Outcomes
Primary Outcome Measures
Change in symptoms from baseline to end of study
Secondary Outcome Measures
Full Information
NCT ID
NCT01558557
First Posted
March 15, 2012
Last Updated
September 25, 2019
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT01558557
Brief Title
Gluten Free Diet in People With Schizophrenia: A Pilot Study
Official Title
Gluten Free Diet in People With Schizophrenia: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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;
Celiac disease (positive tTG antibody); and
Positive assay on Antigliadin antibodies
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gluten Sensitivity, Celiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gluten Free Diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Gluten Free Diet
Intervention Description
Participants will be given a Gluten Free Diet for 2 weeks
Primary Outcome Measure Information:
Title
Change in symptoms from baseline to end of study
Time Frame
Baseline and 2 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deanna L Kelly, Pharm.D., BCPP
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryland Psychiatric Research Center
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gluten Free Diet in People With Schizophrenia: A Pilot Study
We'll reach out to this number within 24 hrs