Questioning the role of palmitoylethanolamide in psychosis: a systematic review of clinical and preclinical evidence.
Riccardo Bortoletto, Fabiana Piscitelli, Anna Candolo...
https://pubmed.ncbi.nlm.nih.gov/37533892Actively Recruiting
Phase Not Applicable
Age: 18Years - 35Years
All Genders
ID06187090
The Supplementation Therapy in Autism and Response to Treatment (START) Study
Led by University of Udine · Updated on 2024-01-02
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to address an important need for adults with Level 1 Autism Spectrum Disorder (ASD) who experience anxiety and depressive symptoms alongside their core autism features. Up to 70% of autistic individuals have another psychiatric disorder that affects their quality of life. The study evaluates the use of palmitoylethanolamide (PEA), a food supplement with anti-inflammatory and neuroprotective properties, to see if it can reduce symptoms of psychic distress in this group. It also looks at the safety and biological effects of PEA in these individuals. Participants will take oral PEA once daily at a dose of 600 mg during a 12-week initial phase. Those who complete this phase may continue in a 24-week extension where the dose can be increased up to 1200 mg daily depending on clinical response. The treatment is taken around mealtime. The study will be conducted at a university hospital's psychiatry unit and involves dispensing the supplement at follow-up visits. Participants will attend a screening visit, baseline visit, and follow-up visits at 4 and 12 weeks during the initial phase, with additional visits at 24 and 36 weeks if continuing in the extension. Assessments include clinical interviews, physical exams, blood and urine tests, stool sample collection, and questionnaires to measure anxiety, depression, disability, and symptom severity. Researchers will monitor treatment adherence, side effects, and biological markers related to immune response and gut microbiota. The total study duration for participants can be up to 36 weeks.
CONDITIONS
Brief Title
The Supplementation Therapy in Autism and Response to Treatment Study
Who Can Participate
Age: 18Years - 35Years
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals diagnosed with Level 1 Autism Spectrum Disorder (ASD) as defined by DSM-5
- Aged between 18 and 35 years
- Able to understand and communicate in Italian
- Able to give informed consent
You will not qualify if you...
- Diagnosed with Level 2 or Level 3 Autism Spectrum Disorder as defined by DSM-5
- Current diagnosis of a major psychiatric disorder such as major depressive disorder, bipolar disorder, or psychotic disorders
- Active suicidal thoughts or significant suicide risk
- History of neurological disorders like epilepsy (except febrile convulsions) or severe physical illness
- Currently using psychotropic medications except stable SSRI monotherapy for at least 8 months
- IQ below 70
- Female participants who are pregnant, breastfeeding, or not using effective contraception if at risk of pregnancy
- Currently participating in another pharmacological clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 visits (in-person) prior to baseline for consent, eligibility assessment, physical examination, and safety labs
Treatment
Duration - 12 weeks
Participants take oral Palmitoylethanolamide (PEA) once daily for 12 weeks to help alleviate symptoms of anxiety and depression associated with Level 1 Autism Spectrum Disorder. During this time, assessments and sample collections will be performed to monitor symptoms, biological effects, and side effects.
3 visits (in-person) including baseline and follow-ups at Weeks 4 and 12
Treatment
Duration - Up to 24 weeks
Participants who complete the initial 12-week phase may continue PEA treatment for up to an additional 24 weeks, with possible dose adjustment from once to twice daily based on clinical response. Continued monitoring of symptoms, biological markers, and side effects will take place during this extension phase.
2 visits (in-person) at approximately Weeks 24 and 36 for those enrolled in extension
Trial Site Locations
Total: 1 location
1
Unit of Psychiatry, University Hospital of Udine
Udine, UD, Italy, 33100
Actively Recruiting
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Research Team
M
Marco Colizzi, MD, PhD
R
Riccardo Bortoletto, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Palmitoylethanolamide and Its Biobehavioral Correlates in Autism Spectrum Disorder: A Systematic Review of Human and Animal Evidence.
Marco Colizzi, Riccardo Bortoletto, Rosalia Costa...
https://pubmed.ncbi.nlm.nih.gov/33919499Therapeutic effect of palmitoylethanolamide in cognitive decline: A systematic review and preliminary meta-analysis of preclinical and clinical evidence.
Marco Colizzi, Riccardo Bortoletto, Chiara Colli...
https://pubmed.ncbi.nlm.nih.gov/36387000Is It Time to Test the Antiseizure Potential of Palmitoylethanolamide in Human Studies? A Systematic Review of Preclinical Evidence.
Riccardo Bortoletto, Matteo Balestrieri, Sagnik Bhattacharyya...
https://pubmed.ncbi.nlm.nih.gov/35053844Palmitoylethanolamide as adjunctive therapy for autism: Efficacy and safety results from a randomized controlled trial.
Mona Khalaj, Amene Saghazadeh, Elham Shirazi...
https://pubmed.ncbi.nlm.nih.gov/29807317