Psilocybin for Treatment-Resistant Depression in Autism With Pre-Post Brain and Cognitive Measurement to Understand Mechanisms (PAT-DA)

This open-label Phase I trial (n=20) will investigate the feasibility, tolerability, and safety of administering psilocybin (10mg safety dose, followed by 25mg treatment dose) in autistic adults with treatment-resistant depression (TRD).

The study, conducted by the Centre for Addiction and Mental Health in Toronto, Canada, will involve intellectually able autistic adults aged 18-65 who have not responded to at least two antidepressant treatments.

Participants will receive approximately 20 hours of structured psychotherapy alongside two psilocybin dosing sessions, spaced one week apart. Researchers aim to assess antidepressant effects, changes in brain function using MRI scans, and subjective psychedelic experiences. Safety and feasibility outcomes will be measured using participant retention rates and assessments of adverse effects. The study is expected to run from December 2024 to August 2027.

You can find the trial protocol here.

Topic Autism Depression Treatment-Resistant Depression Neuroscience Safety
Compound Psilocybin
Country Canada
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