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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 : September 27, 2019
Information provided by (Responsible Party):
MPRC, University of Maryland, Baltimore

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;

  1. Celiac disease (positive tTG antibody); and
  2. Positive assay on Antigliadin antibodies

Condition or disease Intervention/treatment Phase
Gluten Sensitivity Celiac Disease Other: Gluten Free Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gluten Free Diet in People With Schizophrenia: A Pilot Study
Study Start Date : June 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Gluten Free Diet Other: Gluten Free Diet
Participants will be given a Gluten Free Diet for 2 weeks

Primary Outcome Measures :
  1. Change in symptoms from baseline to end of study [ Time Frame: Baseline and 2 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558557

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United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland, Baltimore
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Principal Investigator: Deanna L Kelly, Pharm.D., BCPP Principal Investigator
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Responsible Party: MPRC, Deanna L. Kelly, Pharm.D., BCPP, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT01558557    
Other Study ID Numbers: HP-00041292
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Celiac Disease
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases