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

Bortoletto R, Garzitto M, Basaldella M, Scipioni C, Sepulcri O, Fabris M, Curcio F, Balestrieri M, Colizzi M. Brain, Behavior, & Immunity - Health, 2025; 50:101141.

Open-label, no control groupHumans

Design
Open-label, no control group
Subjects
16 people at clinical high risk of psychosis enrolled. 15 completed.
Dose used in the study
600 mg a day of ultramicronised palmitoylethanolamide, added to usual treatment
Duration
12 weeks
What was measured
The intensity of attenuated psychotic symptoms on the CAARMS scale. Anxiety, depression, functioning and blood markers of inflammation.

What the authors reported

The total symptom score fell by 30% and the unusual thought content score by 52.5% at 12 weeks. Anxiety and depression scores also improved. No side effects were reported.

Limits of this study

A single-group study of 16 people with no randomisation, blinding or comparison group, which the authors name as limits. The blood marker analyses were exploratory. The study had no specific funding. One author disclosed consulting for pharmaceutical companies.

Source

doi:10.1016/j.bbih.2025.101141

Entry checked against the full text at the publisher (ScienceDirect) on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.