Endocannabinoid Activity Remodulation for Psychosis Liability in Youth

Launched by UNIVERSITY OF UDINE · Sep 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called palmitoylethanolamide (PEA) on young adults who are at high risk for developing psychosis. Participants in this study will be individuals aged 18 to 35 who show signs of psychological distress, but have not yet experienced a full-blown psychotic episode. The goal is to see if taking PEA daily for 12 weeks can help reduce symptoms like anxiety and unusual thoughts, while also checking how safe it is for those involved.

If you or someone you know meets the eligibility criteria, which includes being able to communicate in Italian and giving informed consent, you could participate in this study. Participants will take one tablet of PEA (600 mg) each day with a meal and will have regular check-ups to monitor their progress and any side effects. After the initial 12 weeks, there’s a chance to continue for another 24 weeks to see how well the treatment works over a longer period. This study aims to fill a gap in treatment options for young adults facing these challenges and could lead to new ways to support their mental health.

Gender

ALL

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.