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NCT03183609 · ClinicalTrials.gov registry record · NA
Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)
A NA study of Schizophrenia and Schizoaffective Disorder, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03183609: Completed NA study of Schizophrenia and Schizoaffective Disorder, sponsored by University of Maryland, Baltimore.
NCT03183609 is a NA study of Schizophrenia and Schizoaffective Disorder that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 40 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03183609, a NA study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This study purpose is to conduct a confirmatory double-blind randomized controlled trial in an inpatient setting of the effects of a tightly controlled gluten-free diet (GFD) to improve negative symptoms in people with schizophrenia or schizoaffective disorder who have antibodies to gliadin (AGA IgG). As part of the project investigators will also confirm outcomes such as cognitive symptoms, changes in peripheral and central inflammation as well as gut/blood brain barrier permeability.
Primary Outcome
This will be measured by the difference in Clinical Assessment of Negative Symptoms -Motivation and Pleasure scale CAINS-MAP) score from baseline to week 5, with a lower score yielding a better outcome.
Conditions Studied
Interventions
- OTHER Gluten Flour in Protein Shake
- OTHER Rice Flour in Protein Shake
Study Locations (1)
Maryland
- Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP) - Catonsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2024-03-30 |
| Phase | NA |
What the finished NCT03183609 record still lists
NCT03183609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Gluten Flour in Protein Shake is the first listed.
NCT03183609 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03183609 about?
NCT03183609 is a clinical study titled "Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)". This study purpose is to conduct a confirmatory double-blind randomized controlled trial in an inpatient setting of the effects of a tightly controlled gluten-free diet (GFD) to improve negative symptoms in people with schizophrenia or schizoaffective disorder who have antibodies to gliadin (AGA IgG...
What is the current status of trial NCT03183609?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2017-07-10. Estimated completion is 2024-03-30.
What conditions does trial NCT03183609 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder, Gluten Sensitivity.
What interventions are being tested in trial NCT03183609?
The interventions under investigation include: Gluten Flour in Protein Shake (OTHER), Rice Flour in Protein Shake (OTHER).
Who is sponsoring clinical trial NCT03183609?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03183609 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03183609's enrollment target sits among peer trials
40 233rd of 315 higher than 73 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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