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

Study 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

Primary Outcome

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.

Interventions

• OTHER Gluten Free Flour
• OTHER Wheat Flour