Supplementation therapy for anxiety and depression in autistic individuals
The Supplementation Therapy in Autism and Response to Treatment (START) Study
This study is testing if a supplement called PEA can help reduce anxiety and depression in young adults with Level 1 Autism Spectrum Disorder who haven't found relief with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | University of Udine Academic / other |
| Locations | 1 site (Udine, UD) |
| Trial ID | NCT06187090 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18-35 diagnosed with Level 1 ASD who experience comorbid anxiety and/or depressive symptoms.
Not a fit: Patients with Level 2 or Level 3 ASD or those with major psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for managing anxiety and depressive symptoms in autistic individuals.
How similar studies have performed: While the therapeutic potential of endocannabinoid modulation is gaining interest, this specific approach using PEA in this population is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Udine, UD
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.