Psilocybin for Treatment-Resistant Depression in Autism (NCT06731621) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Canada20 participantsStarted 2024-11-01
Plain-language summary
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)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be aged 18 to 65 years old;
. Must be deemed to have capacity to provide informed consent;
. Ability to read and communicate in English;
. Must sign and date the informed consent form;
. Stated willingness to comply with all study procedures;
. Intellectually able: Either 1) the participant has a previous report showing intelligence quotient (IQ) ≥ 70 on the General Abilities Index of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) or any other standardized intelligence scales, or 2) the participant scores \>10 percentile on the nine-item form of the Raven's Standard Progressive Matrices Test (RSPM).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Administering Psilocybin in Conjunction with Psychotherapy in Autistic Adults
Timeframe: From enrollment to end of treatment & follow-up at 12 weeks post-intervention (12 weeks post treatment dosing i.e., Day 0)
2
Subjective Psychedelic Effects as Measured by the 11-Dimensions of Altered States of Consciousness (11D-ASC) Rating Scale
Timeframe: Administered following each dosing session (Visit 3 (Safety dosing - Day -7)) & Visit 4 (treatment dosing - Day 0))
3
Number of Participants with Treatment-Related Adverse Events as Assessed by SBQ-ASC & UKU Side Effect Rating Scale
Timeframe: From enrollment to end of treatment & follow-up at 12 weeks post-intervention (12 weeks post treatment dosing i.e., Day 0)
4
Feasibility of Dense Sampling Brain MRI Procedures & Trial Design
Timeframe: From enrollment to end of treatment & follow-up at 12 weeks post-intervention (12 weeks post-treatment dosing i.e., Day 0)
. Clinical diagnosis of autism spectrum disorder (ASD), based on the DSM-5 or ICD-11
. Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the Mini International Neuropsychiatric Interview (MINI) administered at the first screening visit (V1);
Exclusion criteria
. Pregnant as assessed by a urine pregnancy test or individual's that intend to become pregnant during the study or are breastfeeding;
. Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
. The presence of an unstable seizure disorder as defined by having not been seizure-free for at least 6 months or anticonvulsant treatment has not been stable for at least 4 weeks;
. The presence of any clinically significant or unstable medical conditions, including cardiovascular, liver, kidney, pulmonary disease, presence of known congenital brain malformation, as per investigator assessment based on medical history and chart review;
. Moderate or severe DSM-5 diagnosis of an alcohol or substance use disorder in the past 12 months;
. Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, or neurocognitive disorder as determined by medical history and the MINI clinical interview;
. Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant;
. Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment;