Study of Oral Palmitoylethanolamide PEA Supplementation for Anxiety and Depression in Adults with Level 1 Autism Spectrum Disorder Aged 18 to 35

What this Trial Is About

This research aims to address an important need for adults with Level 1 Autism Spectrum Disorder ASD who experience anxiety and depressive symptoms alongside their core autism features. Up to 70% of autistic individuals have another psychiatric disorder that affects their quality of life. The study evaluates the use of palmitoylethanolamide PEA, a food supplement with anti-inflammatory and neuroprotective properties, to see if it can reduce symptoms of psychic distress in this group. It also looks at the safety and biological effects of PEA in these individuals. Participants will take oral PEA once daily at a dose of 600 mg during a 12-week initial phase. Those who complete this phase may continue in a 24-week extension where the dose can be increased up to 1200 mg daily depending on clinical response. The treatment is taken around mealtime. The study will be conducted at a university hospitals psychiatry unit and involves dispensing the supplement at follow-up visits. Participants will attend a screening visit, baseline visit, and follow-up visits at 4 and 12 weeks during the initial phase, with additional visits at 24 and 36 weeks if continuing in the extension. Assessments include clinical interviews, physical exams, blood and urine tests, stool sample collection, and questionnaires to measure anxiety, depression, disability, and symptom severity. Researchers will monitor treatment adherence, side effects, and biological markers related to immune response and gut microbiota. The total study duration for participants can be up to 36 weeks.

The Supplementation Therapy in Autism and Response to Treatment Study