Actively Recruiting
Psilocybin for Treatment-Resistant Depression in Autism
Led by Centre for Addiction and Mental Health · Updated on 2026-03-20
20
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized psychotherapy that has previously been used with psilocybin (Agin-Liebes et al., 2020). They will also receive psilocybin at 2 different time points, firstly a safety dose of 10mg, followed by a treatment dose of 25mg. This study design is in accordance with previous studies investigating the use of psilocybin with psilocybin-assisted therapy (PAT) to treat TRD (Carhart-Harris et al., 2016, 2018)
CONDITIONS
Official Title
Psilocybin for Treatment-Resistant Depression in Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Able to provide informed consent
- Able to read and communicate in English
- Signed informed consent form
- Willing to comply with all study procedures
- Intellectually able with IQ 60 70 on WAIS-IV or equivalent, or >10 percentile on Raven's Standard Progressive Matrices
- Clinical diagnosis of autism spectrum disorder (ASD) based on DSM-5 or ICD-11
- Primary diagnosis of non-psychotic major depressive disorder (MDD), single or recurrent
- Treatment-resistant depression with baseline GRID-HAMD-17 score >14 and no response to two or more adequate antidepressant trials
- Able to take oral medication
- If capable of becoming pregnant, using highly effective contraception for at least 3 months prior and during the study
- Willing to taper off current antidepressant and antipsychotic medications safely prior to baseline
- Clean urine drug screen and negative urine pregnancy test (if female)
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Treatment with another investigational drug or intervention within 30 days of screening
- Unstable seizure disorder or unstable anticonvulsant treatment
- Clinically significant or unstable medical conditions including cardiovascular, liver, kidney, or pulmonary disease
- Moderate or severe alcohol or substance use disorder in past 12 months
- Lifetime diagnosis of schizophrenia-spectrum, psychotic disorders (except substance-induced), bipolar I or II, paranoid personality, or neurocognitive disorders
- First-degree relative with schizophrenia-spectrum, psychotic, or bipolar disorders
- Contraindications to psilocybin such as allergy, recent stroke, uncontrolled hypertension, recent myocardial infarction, arrhythmia, severe coronary artery disease, or significant renal/hepatic impairment
- Extensive lifetime or recent use of ketamine, psychedelics, or MDMA
- Any other major physical illness or infection that may interfere with study or pose health risk
- Active suicidal ideation with intent and plan
- New psychotherapy initiated within 12 weeks prior to screening
- Contraindication to MRI or history of claustrophobia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Actively Recruiting
Research Team
H
Hsiang-Yuan Lin, MD
CONTACT
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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