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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 26, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT06731621). This is a study registration, not published results. Lead sponsor: Centre for Addiction and Mental Health. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 18 participants (ACTUAL). Conditions: Treatment Resistant Depression, Autism Spectrum Disorder. Interventions: DRUG: Psilocybin. Primary outcome measures: Feasibility of Administering Psilocybin in Conjunction with Psychotherapy in Autistic Adults , From enrollment to end of treatment & follow-up at 12 weeks post-intervention (12 weeks post treatment dosing i.e., Day 0); Subjective Psychedelic Effects as Measured by the 11-Dimensions of Altered States of Consciousness (11D-ASC) Rating Scale , Administered following each dosing session (Visit 3 (Safety dosing - Day -7)) & Visit 4 (treatment dosing - Day 0)); Number of Participants with Treatment-Related Adverse Events as Assessed by SBQ-ASC & UKU Side Effect Rating Scale , From enrollment to end of treatment & follow-up at 12 weeks post-intervention (12 weeks post treatment dosing i.e., Day 0); Feasibility of Dense Sampling Brain MRI Procedures & Trial Design , From enrollment to end of treatment & follow-up at 12 weeks post-intervention (12 weeks post-treatment dosing i.e., Day 0). Brief 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 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, separated by a week. 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)