Ignite Creation Date:
2024-05-06 @ 1:52 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01927276
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2013-08-19
Brief Title:
Randomized Controlled Trial of a Gluten Free Diet In Patients With Schizophrenia Who Are Gliadin-Positive
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Randomized Controlled Trial of a Gluten Free Diet In Patients With Schizophrenia Who Are Gliadin-Positive
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Out of 300 million persons in the United States about one-half of one percent or 15 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 300000 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 publics 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
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 300000 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 publics 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None