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Randomized Controlled Trial of a Gluten Free Diet In Patients With Schizophrenia Who Are Gliadin-Positive

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ClinicalTrials.gov Identifier: NCT01927276
Recruitment Status : Completed
First Posted : August 22, 2013
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Deanna Kelly, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE August 19, 2013
First Posted Date  ICMJE August 22, 2013
Last Update Posted Date September 27, 2019
Study Start Date  ICMJE September 1, 2013
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
To test the efficacy of a gluten free diet in people with schizophrenia who are gliadin positive. [ Time Frame: 5 weeks ]
We will examine positive and negative symptoms changes during a five week inpatient clinical trial. The funding of this study is to develop the feasibility and pilot data to complete a large scale future trial.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01927276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
To test the feasibility of gluten-free diet maintenance [ Time Frame: 5 weeks ]
We will pilot the development of educational planning and procedures to test adherence to the gluten-free diet for at least two months after the inpatient phase is complete.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of a Gluten Free Diet In Patients With Schizophrenia Who Are Gliadin-Positive
Official Title  ICMJE Randomized Controlled Trial of a Gluten Free Diet In Patients With Schizophrenia Who Are Gliadin-Positive
Brief Summary

Out of 300 million persons in the United States, about one-half of one percent, or 1.5 million, have a diagnosis of schizophrenia. Schizophrenia begins in young adulthood, and often is chronic and disabling for the remainder of the life course], which is shorter than for the general population by as much as 25 years. The costs of schizophrenia in the United States are estimated to be between $30 and $60 billion dollars annually. Treatment for schizophrenia is only marginally successful: in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), for example, the medication prescribed at the beginning of the trial was stopped or changed in nearly 75% by the completion of the trial 18 months later. The medications have limited effect on negative symptoms or cognitive impairments of schizophrenia, and many have severe and permanent side effects. The basic hypothesis underlying treatment for schizophrenia has not changed for more than half a century. New treatments are needed.

Much accumulating evidence suggests that sensitivity to gluten may be related to symptoms or etiology in schizophrenia and that gluten free diets may lead to significant symptom resolution, but only in patients who are known to have antibodies to gluten.

Gluten sensitivity may be more common than thought and stems from a different etiology and symptom presentation than Celiac Disease. The investigators analysis of the CATIE sample show that about 23% of persons with schizophrenia (compared to 3% of healthy controls) have Gluten Sensitivity (about 300,000 persons in the United States) through the identification of gliadin positive antibodies in their blood. The investigators hypothesize that people with this biomarker could have robust symptom improvements with the removal of the antigen from the diet (gluten). If only half of people with schizophrenia and these antibodies were to substantially benefit from removal of gluten from the diet, as in the case studies and with certain subjects in the clinical trials, this would provide a new transformative treatment option for an identifiable subpopulation of people with schizophrenia and would be of enormous benefit to patients, families and society. Another benefit to the public's health from this study will be enhanced knowledge of the etiology of schizophrenia, including possible linkages between neuropsychiatric disease and immune system activation, and identification of novel, immune-linked treatment targets.

The results of this research could lead to screening for Anti-Gliadin Antibodies early in life or at the first episode of schizophrenia, as recommended by some already. Screening involves financial and emotional costs, and better evidence is needed before this recommendation can be justified. Moreover, a new treatment paradigm of removing gluten from the diet by means of gluten blocking medications (already in early study) could advance treatment significantly.

This study will test the efficacy, in a pilot fashion, of 20 participants in a double blind five week randomized placebo controlled gluten free diet vs identical diet with gluten in gliadin-positive individuals with schizophrenia. Approximately equal numbers will receive the addition of gluten, or non-gluten starch, in identical form (given as flour in food). The investigators plan to develop mechanisms and procedures to locate, screen, and recruit subjects into the inpatient intervention study, retain them during the inpatient phase. Once admitted baseline assessments may take approximately a few days but will be mostly completed in the first week prior to the 5 week randomization, thus patients may stay longer than 5 weeks. At the end of the double blind trial the investigators will prepare for discharge and then test the feasibility of successfully maintaining gluten free diets after the intervention phase is complete, for at least two months.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Other: Gluten Free Flour
  • Other: Wheat Flour
Study Arms  ICMJE
  • Placebo Comparator: Gluten Free Flour (Control)
    Gluten Free Flour 10 grams daily
    Intervention: Other: Gluten Free Flour
  • Active Comparator: Wheat Flour
    Wheat Flour 10 grams daily
    Intervention: Other: Wheat Flour
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2017)
26
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2013)
90
Actual Study Completion Date  ICMJE May 1, 2017
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  2. positive for antibodies to gliadin (determined by positive assay in screening protocol)
  3. BPRS total score ≥29
  4. Age 18- 45 years
  5. Same antipsychotic for at least 4 weeks
  6. Ability to consent determined by a score of 10 or greater on the Evaluation to Sign Consent.

Exclusion Criteria:

  1. Persons already on gluten free diets
  2. Pregnant or lactating females
  3. Organic brain disorder or mental retardation
  4. Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
  5. Meets DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
  6. Gluten ataxia, assessed by the International Cooperative Ataxia Rating Scale (ICARS)[15]
  7. Inability to provide informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01927276
Other Study ID Numbers  ICMJE HP-00056339
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deanna Kelly, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Maryland, Baltimore
Verification Date September 2019

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