Evidence map›Paper›PMID 41378189›Full record

ArticleBrain, behavior, & immunity - health2025

Effects of palmitoylethanolamide in clinical high-risk for psychosis: A nonrandomized open-label trial.

Riccardo Bortoletto, Marco Garzitto, Marta Basaldella, Claudia Scipioni, Orietta Sepulcri, Martina Fabris, Francesco Curcio, Matteo Balestrieri, Marco Colizzi

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Brain, behavior, & immunity - health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06037993 (Endocannabinoid Activity Remodulation for Psychosis Liability in Youth), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT06037993 naunknown statusnot on this map

Endocannabinoid Activity Remodulation for Psychosis Liability in Youth (EARLY)

TypeinterventionalSponsorUniversity of UdineRan2022 to 2025Enrolled20ConditionsClinical High Risk for Psychosis, Ultra High Risk for Psychosis, Attenuated Psychotic SymptomsArmsUltra-micronized Palmitoylethanolamide (PEA)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Riccardo BortolettoUnit of Psychiatry and Eating Disorders, Department of Medicine (DMED), University of Udine, Udine, 33100, Italy.
Marco GarzittoUnit of Psychiatry and Eating Disorders, Department of Medicine (DMED), University of Udine, Udine, 33100, Italy.
Marta BasaldellaUnit of Psychiatry and Eating Disorders, Department of Medicine (DMED), University of Udine, Udine, 33100, Italy.
Claudia ScipioniUnit of Psychiatry and Eating Disorders, Department of Medicine (DMED), University of Udine, Udine, 33100, Italy.
Orietta SepulcriUnit of Psychiatry and Eating Disorders, Friuli Centrale Health University Authority (ASUFC), 33100, Udine, Italy.
Martina FabrisInstitute of Clinical Pathology, Department of Medicine (DMED), University of Udine Udine, 33100, Italy.
Francesco CurcioInstitute of Clinical Pathology, Department of Medicine (DMED), University of Udine Udine, 33100, Italy.
Matteo BalestrieriUnit of Psychiatry and Eating Disorders, Department of Medicine (DMED), University of Udine, Udine, 33100, Italy.
Marco ColizziUnit of Psychiatry and Eating Disorders, Department of Medicine (DMED), University of Udine, Udine, 33100, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clinical high-risk (CHR) for psychosis state still lacks effective and safe treatments. Recent evidence supports the anti-neuroinflammatory properties of fatty acid palmitoylethanolamide (PEA) dietary supplementation across the psychosis spectrum. Sixteen subjects at CHR for psychosis with attenuated psychotic symptoms (APS) enrolled in a 12-week, open-label, nonrandomized, single-arm clinical trial of ultramicronized-PEA (um-PEA, 600 mg/day). Biobehavioral assessments were conducted at baseline, 4 weeks, and 12 weeks, particularly using the Comprehensive Assessment of At-Risk Mental States (CAARMS) and quantifying changes in peripheral neuroimmune biomarkers. Linear mixed-effects models showed significant reductions in CAARMS total APS (Δ Trial registration: ClinicalTrials.gov Identifier NCT06037993.

Identifiers

PMID41378189
PMCPMC12689190

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Registered trials

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 OpenQuestion graph.