Using Palmitoylethanolamide to Prevent Psychosis in Young People

Endocannabinoid Activity Remodulation for Psychosis Liability in Youth (EARLY)

This study is testing if a natural supplement called palmitoylethanolamide can help young people at risk of developing psychosis by preventing their symptoms from getting worse.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 35 Years
• Sex: All
• Sponsor: University of Udine (Academic / other)
• Locations: 2 sites (Udine, UD and 1 other locations)
• Trial ID: NCT06037993 on ClinicalTrials.gov

What this trial studies

This study aims to address the unmet clinical need for effective interventions in individuals at clinical high risk for psychosis, particularly those experiencing attenuated psychotic symptoms. Participants aged 18-35 will receive oral therapy with palmitoylethanolamide (PEA), a nutraceutical known for its anti-inflammatory and neuroprotective properties. The study will evaluate the safety and efficacy of PEA in preventing the progression to full-blown psychosis over a specified period. By targeting the endocannabinoid system, the research seeks to modulate underlying inflammatory processes associated with psychological distress.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18-35 diagnosed with clinical high-risk for psychosis and able to communicate in Italian.

Not a fit: Patients with a history of psychotic episodes or severe neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of developing full-blown psychotic disorders in at-risk youth.

How similar studies have performed: While the use of PEA is promising, this specific approach targeting psychosis liability in youth is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria

* Individuals diagnosed with CHR-APS, as defined using CAARMS criteria;
* Aged 18-35 years;
* To be able to understand and communicate in Italian;
* To be able to give informed consent.

Exclusion Criteria

* Lifetime history of a psychotic or manic episode lasting 7 days or longer;
* Active suicidal ideation indicating significant current risk or history of serious suicide attempt in the opinion of the PI, as evaluated at the screening stage;
* Lifetime neurological disorders (e.g., epilepsy, except febrile convulsions) or severe intercurrent physical illness;
* Current treatment with psychotropic medication, with the exception of Selective Serotonin Reuptake Inhibitor (SSRI) stable monotherapy (at least 8 months);
* Lifetime treatment with antipsychotic medication for more than 7 days;
* IQ \< 70;
* Female patients who are pregnant, lactating or not using an acceptable effective form contraception if they are at risk of falling pregnant;
* Taking part in another pharmacological trial.

Where this trial is running

Udine, UD and 1 other locations

• Unit of Psychiatry, University Hospital of Udine — Udine, Ud, Italy (Recruiting)
• Unit of Psychiatry, University Hospital of Udine — Udine, Italy (Recruiting)

Study contacts

• Principal investigator: Marco Colizzi, MD, PhD — University of Udine
• Study coordinator: Marco Colizzi, MD, PhD

Conditions Clinical High Risk for Psychosis; Ultra High Risk for Psychosis; Attenuated Psychotic Symptoms; At-Risk Mental State; Schizophrenia; Endocannabinoid System; Gut-Brain Axis; Palmitoylethanolamide