The Supplementation Therapy in Autism and Response to Treatment Study

Conditions studied

Autism, Autism Spectrum Disorder, Autism Spectrum Disorder High-Functioning, Asperger Syndrome, Depressive Symptoms, Anxiety State

About this study

In addition to the "core" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. To date, the first-line treatment for autistic patients with comorbid depressive and/or anxiety symptoms is still debated and it is not always clear whether they may or may not benefit from psychotherapeutic and conventional psychopharmacological approaches. As such, growing evidence strengthens the therapeutic potential of the endocannabinoid (eCB) system modulation and of eCB-like compounds. The aim of this study is to provide a response to an unmet clinical need in this framework of psychic vulnerability by initiating oral therapy with palmitoylethanolamide (PEA), a nutraceutical/food supplement with proven anti-inflammatory and neuroprotective properties. Indeed, many conditions of psychological distress are thought to be underpinned by systemic inflammatory and/or neuroinflammatory processes, on which PEA has shown remarkable efficacy, including through modulation of the immune response and the interaction between the endocannabinoid system and the gut-microbiota-brain axis. The trial we are proposing is a 12-week open-label phase 2 study involving the daily intake of PEA 600 mg, at a dosage of 1 tablet/day. This study will be conducted at the Unit of Psychiatry of Santa Maria della Misericordia Udine University Hospital. Through this study, we wish to evaluate: the ability of PEA to alleviate symptoms of psychic distress (i.e., anxiety and/or depression) in Level 1 autistic adults; the safety and tolerability of sustained intake of PEA in Level 1 autistic adults; and the biological basis of PEA functioning. The study involves taking PEA orally once daily (600 mg daily) at the same time as a meal during the initial 12-week phase. Upon completion of the initial phase, subjects will be offered to enter an extension phase of the trial of an additional 24 weeks to assess treatment stability, with the possibility of titration of PEA to 1200 mg daily based on observed clinical compensation. Each participant…

Interventions

• Dietary Supplement: Oral Ultramicronized-Palmitoylethanolamide (um-PEA; 600 mg per day) in tablet form — Um-PEA is to be taken orally once a day (600 mg per day) around mealtime during the 12-week initial phase of the study. During the 24-week extension phase of the study, the trial medication is to be taken from once a day up to twice a day (600-1200 mg per day), based on clinical judgment of the improvement obtained so far, around mealtime.

Primary outcomes

• Symptom-Checklist-90-R (12 weeks for the initial phase, further 24 weeks for the extension phase)

Eligibility information

Study locations

• Unit of Psychiatry, University Hospital of Udine, Udine, UD 33100 Italy