Psilocybin for Treatment-Resistant Depression in Autism: a Pilot Trial With Pre-Post Brain and Cognitive Measurement to Understand Mechanism
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)
- Status
- recruiting
- Phase
- Phase 1
- Institution
- Centre for Addiction and Mental Health
- Principal investigator
- Hsiang-Yuan Lin, MD
- Start date
- 2024-11-01
- End date
- 2027-08-01
- Registry ID
- NCT06731621
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.