Gluten Free Diet in People With Schizophrenia: A Pilot Study

NCT01558557 | Completed

• 1 other identifier: HP-00041292
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Gluten Sensitivity; Celiac Disease

Outcome Measures

Primary Outcomes (1)

• Change in symptoms from baseline to end of study

  Baseline and 2 Weeks

Study Arms (1)

Gluten Free Diet

EXPERIMENTAL

Other: Gluten Free Diet

Interventions

Gluten Free Diet OTHER

Participants will be given a Gluten Free Diet for 2 weeks

Gluten Free Diet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating women will be excluded. Pregnancy will be determined by pregnancy test. Lactating will be determined by participant report.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Deanna L Kelly, Pharm.D., BCPP

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deanna L. Kelly, Pharm.D., BCPP

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 20, 2012
• Study Start: June 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

US (1)