Supplementation therapy for anxiety and depression in autistic individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effects of oral Ultramicronized-Palmitoylethanolamide (PEA) on alleviating anxiety and depressive symptoms in individuals with Level 1 Autism Spectrum Disorder (ASD). It will assess the safety, tolerability, and biological mechanisms of PEA over a 12-week treatment period. The study will recruit eligible participants aged 18-35 who can communicate in Italian and provide informed consent. The focus is on addressing the unmet clinical needs of autistic individuals who do not respond well to conventional treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Unit of Psychiatry, University Hospital of Udine
  Udine, Ud, Italy Recruiting

Study contacts

• Principal investigator: Marco Colizzi, MD, PhD — Unit of Psychiatry, Department of Medicine (DAME), University of Udine (UNIUD)
• Study coordinator: Marco Colizzi, MD, PhD
• Email: marco.colizzi@uniud.it
• Phone: +390432559155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.