The Supplementation Therapy in Autism and Response to Treatment Study

Launched by UNIVERSITY OF UDINE · Dec 15, 2023

Keywords

ClinConnect Summary

The "Supplementation Therapy in Autism and Response to Treatment Study" is investigating how a supplement called palmitoylethanolamide (PEA) can help reduce anxiety and depression in adults with Level 1 Autism Spectrum Disorder (ASD). Many individuals with ASD face not only challenges with communication and social interaction but also experience mental health issues like anxiety and depression, which can affect their quality of life. This study aims to see if taking PEA daily for 12 weeks can help alleviate these symptoms and to assess its safety and how it works in the body.

To participate in this study, individuals must be between 18 and 35 years old, diagnosed with Level 1 ASD, and able to communicate in Italian. Participants will take one PEA tablet (600 mg) each day with food and will have regular check-ups to monitor their progress and any side effects. The study is taking place at the Santa Maria della Misericordia Udine University Hospital and offers a structured approach to evaluating the effects of this supplement on mental health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals diagnosed with Level 1 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5);
• • Aged 18-35 years;
• • To be able to understand and communicate in Italian;
• • To be able to give informed consent.
• Exclusion Criteria:
• • Level 2 or Level 3 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) \[47\];
• • Current diagnosis of a co-occurring major psychiatric disorder (e.g., major depressive disorder, bipolar affective disorder, psychotic disorders);
• • 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);
• • 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.