Overview

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

Status:
RECRUITING

Trial end date:
2027-08-01

Target enrollment:

Participant gender:

Summary

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)

Phase:

PHASE1

Details

Lead Sponsor:

Centre for Addiction and Mental Health

Treatments:

Psilocybin