The Endocannabinoid Activity Remodulation for Psychosis Liability in Youth (EARLY) Study: An Open-Label Feasibility Trial of Ultramicronized-Palmitoylethanolamide Oral Supplementation in Clinical High-Risk State for Psychosis
Open-label, no control groupHumans
- Design
- Open-label, no control group
- Subjects
- Planned enrolment of 20 young adults at clinical high risk for psychosis with attenuated psychotic symptoms
- Dose used in the study
- Ultramicronised PEA (um-PEA) 600 mg/day, oral
- Duration
- 12-week open-label phase, with an optional 24-week extension
- What was measured
- Feasibility of enrolment; attenuated psychotic symptoms and psychic distress; safety and tolerability; inflammatory response, endocannabinoid signalling and microbiome composition.
What the authors reported
This is a study protocol: it describes a planned single-arm, open-label, proof-of-concept trial and states its aims, but reports no outcome results in the abstract.
Limits of this study
A feasibility protocol, not a completed trial; no outcome data are yet available, and the single-arm open-label design without a control group will limit conclusions once run. One author (M.C.) has consulted for cannabinoid-related pharmaceutical companies outside this work.
Source
PubMed 39766429 · doi:10.3390/brainsci14121230
Entry checked against the abstract on PubMed on 2026-09-22. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.