Psilocybin for Depression in Autism
(PAT-DA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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)
Will I have to stop taking my current medications?
Yes, you will need to taper off your current antidepressant and antipsychotic medications for at least 2 weeks before starting the trial, as long as your doctor confirms it's safe for you to do so.
Is psilocybin generally safe for humans?
Psilocybin has been studied for its safety in humans, showing that while it can cause challenging experiences, the risk of long-term psychological distress or risky behavior is low when used in controlled settings with proper support. Some studies suggest it may be safe for use under medical supervision, but caution is advised, especially for those with heart conditions.12345
How is the drug psilocybin unique in treating depression in autism?
Psilocybin is unique because it acts quickly and may provide long-lasting relief from depression symptoms after just one or a few doses, unlike traditional antidepressants that often require daily use. It works by activating serotonin receptors in the brain, which can lead to changes in mood and perception, and has shown promise in treating various psychiatric disorders with minimal side effects.678910
What data supports the effectiveness of the drug psilocybin for depression in autism?
Research shows that psilocybin has been studied for various psychiatric disorders, including depression, and has been well tolerated with some patients experiencing significant long-term improvements. Although more research is needed, these initial findings are promising for its potential use in treating depression.2491112
Are You a Good Fit for This Trial?
This trial is for adults with autism who also have depression that hasn't improved with standard treatments. Participants should be able to communicate effectively and handle the demands of the study, which includes around 20 hours of specialized psychotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Dosing Session
Participants receive a safety dose of 10mg psilocybin along with therapy and safety evaluations
Active Treatment Session
Participants receive a treatment dose of 25mg psilocybin along with therapy and safety evaluations
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Psilocybin is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Addiction and Mental Health
Lead Sponsor