Randomized Controlled Trial of a Gluten Free Diet In Patients With Schizophrenia Who Are Gliadin-Positive
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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.
    


Intervention name(s): Gluten Free Flour; Wheat Flour
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Schizophrenia; Gluten