Condition: Treatment Resistant Depression · Autism Spectrum Disorder · Sponsor: Centre for Addiction and Mental Health
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)
This description comes directly from the study's public registry record.
Hsiang-Yuan Lin, MD · 416-535-8501 · Hsiang-Yuan.Lin@camh.ca
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| Centre for Addiction and Mental Health | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06731621