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.

Topic Autism Depression Treatment-Resistant Depression Neuroscience Safety
Compound Psilocybin
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 December 2024
End date 01 August 2027
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 65
Therapy Yes

Trial Details

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)

Trial Number NCT06731621

Data attribution

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