Phase 1 Autism Spectrum Disorder Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 65 years old
- You are able to understand and agree to take part in the study on your own behalf
- You can read and communicate in English
- You are willing to sign and date a consent form agreeing to take part
- You are willing to follow all of the study's procedures and requirements
- You have an average or higher level of general thinking ability, shown either by a previous test result or a short test done as part of screening (confirm with trial site)
- You have been formally diagnosed with autism spectrum disorder (ASD) based on recognised diagnostic guidelines
- You have been diagnosed with major depressive disorder (MDD) that is not linked to psychosis, based on a clinical interview at your first screening appointment
- You have depression that has not improved after trying two or more different antidepressant medications at the right dose for long enough — sometimes called treatment-resistant depression — and your current depression score is above a certain level on a standard rating scale
- You are able to swallow tablets or capsules
- If you are able to become pregnant, you have been using highly effective contraception for at least 3 months before screening and agree to continue doing so throughout the study
- You are willing and able (with your doctor's agreement) to gradually stop taking your current antidepressant and antipsychotic medications for at least 2 weeks before the study begins
- You have a clear urine drug test, and if applicable, a negative pregnancy test at screening
Who may not be able to join:
- You are currently pregnant, intending to become pregnant during the study, or are breastfeeding
- You have taken part in another clinical trial or received an experimental treatment within the past 30 days
- You have a seizure disorder that is not well controlled, meaning you have had a seizure in the past 6 months or your seizure medication has not been stable for at least 4 weeks
- You have a significant or unstable physical health condition affecting your heart, liver, kidneys, lungs, or brain structure, as assessed by the study doctor
- You have had a moderate or severe problem with alcohol or drug use in the past 12 months
- You have ever been diagnosed with schizophrenia or a related condition, a psychotic disorder (unless caused by substances or a medical condition), bipolar disorder (type I or II), paranoid personality disorder, or a significant cognitive decline disorder
- A close biological relative (parent, sibling, or child) has been diagnosed with schizophrenia, a psychotic disorder (unless caused by substances or a medical condition), or bipolar disorder
- You have a medical reason why you cannot take psilocybin, such as a drug allergy, recent stroke, uncontrolled high blood pressure, very low or unstable blood pressure, recent heart attack, irregular heartbeat, severe heart disease, or significant kidney or liver problems
- You have used ketamine, psychedelics, or MDMA heavily over your lifetime (more than 10 years total) or in the past 6 months, or your urine drug test is positive for these substances
- You have any other significant physical illness that, in the study doctor's opinion, could affect the results or put your health at risk
- You are currently having thoughts of suicide with a specific plan and intent to act on them
- You have started a new form of talking therapy (psychotherapy) within the past 12 weeks
- You are unable to have an MRI scan, or you have severe claustrophobia (fear of enclosed spaces)
- You are not willing or able to follow the lifestyle guidelines, which include: avoiding alcohol for 24 hours before treatment sessions; avoiding certain medications (opioids, benzodiazepines, sleep aids) around treatment days; avoiding all illegal drugs throughout the study; avoiding cannabis for at least 3 weeks before treatment sessions; and not driving or operating heavy machinery for 24 hours after treatment sessions
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Hsiang-Yuan Lin, MD, Centre for Addiction and Mental Health
Phone: 416-535-8501
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Feasibility of Administering Psilocybin in Conjunction with Psychotherapy in Autistic Adults; Subjective Psychedelic Effects as Measured by the 11-Dimensions of Altered States of Consciousness (11D-ASC) Rating Scale; Number of Participants with Treatment-Related Adverse Events as Assessed by SBQ-ASC & UKU Side Effect Rating Scale; Feasibility of Dense Sampling Brain MRI Procedures & Trial Design
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.