Condition: Autism · Autism Spectrum Disorder · Autism Spectrum Disorder High-Functioning · Sponsor: University of Udine
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 endocanna…
This description comes directly from the study's public registry record.
Marco Colizzi, MD, PhD · +390432559155 · marco.colizzi@uniud.it
Riccardo Bortoletto, MD · +393484739255 · bortoletto.riccardo@spes.uniud.it
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| Unit of Psychiatry, University Hospital of Udine | Udine, UD, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06187090