Evidence map›Paper›PMID 41544406›Full record

Trial reportSchizophrenia research2026

Randomized double-blind inpatient study of a gluten-free diet for negative symptoms in people with schizophrenia.

Deanna L Kelly, Christopher M Lee, Gopal Vyas, Robert W Buchanan, Daniel J Roche, Valerie Harrington, Laura M Rowland, S Andrea Wijtenburg, Bhim M Adhikari, Korrapati V Sathyasaikumar and 11 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Schizophrenia research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Deanna L KellyMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: dlkelly@som.umaryland.edu.
Christopher M LeeDepartment of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA; Sheppard E. Pratt Hospital, Towson, MD, USA.
Gopal VyasMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA; Spring Grove Hospital Center, Maryland Department of Health, Baltimore, MD, USA.
Robert W BuchananMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Daniel J RocheMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Valerie HarringtonMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Laura M RowlandMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
S Andrea WijtenburgMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Bhim M AdhikariMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Korrapati V SathyasaikumarMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Peter KochunovMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Monica V TalorDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
James WaltzMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Fang LiuMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Stephanie HareMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Heather A AdamsMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA; Spring Grove Hospital Center, Maryland Department of Health, Baltimore, MD, USA.
Robert SchwarczMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Deepak SalemDepartment of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA; Sheppard E. Pratt Hospital, Towson, MD, USA.
James M GoldMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
Sarah M ClarkDepartment of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
William W EatonDepartment of Mental Health, Johns Hopkins University School of Public Health, Baltimore, MD, USA.

Funding

Confirmatory Double-Blind Placebo-Controlled Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons with Schizophrenia Who Have High Levels of IgG Anti-Gliadin AntibodiesR01MH113617 · NIMH · UNIVERSITY OF MARYLAND BALTIMORE · PI EATON, WILLIAM W, KELLY, DEANNA L · 2017 to 2021
$4.3M
NIMH NIH HHS R01 MH113617
6 · The paper itself

Abstract

backgroundThere are no FDA-approved treatments for negative symptoms in schizophrenia and related disorders (SRD). In an SRD subgroup with systemic and central inflammation and elevated anti-gliadin immunoglobulin G antibodies (AGA IgG+), previous findings suggested that a gluten-free diet (GFD) improved negative symptoms.

methodsWe conducted a five-week double-blind randomized placebo-controlled inpatient trial comparing a GFD versus a gluten-containing diet (GCD) in people with SRD and elevated AGA IgG+ (N = 39; n = 21 GFD and n = 18 GCD). The Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure (CAINS MAP) scale measured the primary outcome of negative symptoms. Secondary outcomes evaluated other symptom domains and serum kynurenine pathway metabolites. Also, we explored inflammatory markers and, in n = 20 participants, measured cerebral blood flow (CBF) using Arterial Spin Labeling, and neurochemistry using magnetic resonance spectroscopy. OUTCOMES: Relative to a GCD, a GFD was associated with a modest decrease in CAINS MAP scores (df = 31.2.1, F = 2.96, p = 0.035); decrease in kynurenic acid (KYNA; df = 32, F = 9.51, p = 0.0042) and kynurenine (df = 32, F = 11.45, p = 0.0019); and increase in CBF and total creatine in frontal brain regions. KYNA and CAINS MAP change scores were correlated (r = 0.350, p = 0.039) while cognition was not impacted. DISCUSSION: Our preliminary data suggests that a GFD may be associated with modest improvements on experiential negative symptoms within an SRD subgroup. A GFD may be associated with reductions in kynurenine pathway metabolites and increased CBF. Larger and longer studies are needed to confirm negative symptom efficacy in this AGA IgG+ SRD subgroup.

Indexed as

Diet, Gluten-FreeSchizophreniaSchizophrenic PsychologyAdultDouble-Blind MethodFemaleHumansInpatientsKynurenineMaleMiddle AgedPsychiatric Status Rating ScalesYoung AdultKynurenineAnhedoniaAvolitionCytokinesGlutenInflammationKynurenic acidKynurenineMotivationNegative symptomsPleasure

Identifiers

PMID41544406
PMCPMC13403900

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.