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Gluten Free Diet in People With Schizophrenia: A Pilot Study

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ClinicalTrials.gov Identifier: NCT01558557
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland

March 15, 2012
March 20, 2012
January 29, 2014
June 2008
January 2014   (Final data collection date for primary outcome measure)
Change in symptoms from baseline to end of study [ Time Frame: Baseline and 2 Weeks ]
Same as current
Complete list of historical versions of study NCT01558557 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Gluten Free Diet in People With Schizophrenia: A Pilot Study
Gluten Free Diet in People With Schizophrenia: A Pilot Study

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
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Gluten Sensitivity
  • Celiac Disease
Other: Gluten Free Diet
Participants will be given a Gluten Free Diet for 2 weeks
Experimental: Gluten Free Diet
Intervention: Other: Gluten Free Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
4
January 2014
January 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01558557
HP-00041292
No
Not Provided
Not Provided
MPRC, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Deanna L Kelly, Pharm.D., BCPP Principal Investigator
University of Maryland
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP