Psilocybin for Treatment-Resistant Depression in Autism With Pre-Post Brain and Cognitive Measurement to Understand Mechanisms (PAT-DA)
Open-label Phase I study (n=20) assessing feasibility, tolerability and safety of psilocybin (10 mg safety dose then 25 mg treatment dose) with manualised psilocybin-assisted therapy in autistic adults with treatment-resistant depression.
Details
This open-label single-group Phase I trial will enrol 20 intellectually able autistic adults with treatment-resistant depression to evaluate feasibility, tolerability and safety of two oral psilocybin dosing sessions (10 mg safety dose, then 25 mg treatment dose) given approximately 1 week apart.
Participants will receive around 20 hours of manualised psilocybin-assisted psychotherapy spanning preparation, dosing support and integration; outcome measures include clinical depression scales, cognitive and pre–post brain measures to explore mechanisms.