Effects of palmitoylethanolamide in clinical high-risk for psychosis: A nonrandomized open-label trial
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
This open-label trial found:
- 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.
- In exploratory analyses, lower baseline IL-1β was linked to greater improvement in unusual thought content, and changes in the IL-10/IL-6 ratio, interferon-gamma and IL-6 were linked to changes in overall symptom scores.
- 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
PubMed 41378189 · 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.