RecruitingPhase 1NCT06731621

Psilocybin for Treatment-Resistant Depression in Autism

Psilocybin for Treatment-Resistant Depression in Autism: a Pilot Trial With Pre-Post Brain and Cognitive Measurement to Understand Mechanism

Sponsor

Centre for Addiction and Mental Health

Enrollment

20 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Autism Spectrum Disorder Treatment Resistant Depression

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)

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether psilocybin (a compound found in certain mushrooms) can help treat severe, treatment-resistant depression in adults who also have autism spectrum disorder (ASD). Most depression treatments have not been well studied in this population. **You may be eligible if...** - You are 18–65 years old - You have a confirmed diagnosis of autism spectrum disorder (ASD) - You have been diagnosed with major depressive disorder (MDD) that has not responded to multiple antidepressants - You have an IQ of 70 or above - You are able to read and communicate in English - You are willing and able to give informed consent **You may NOT be eligible if...** - You have a history of psychosis or schizophrenia - You have serious heart conditions or certain other medical conditions - You are currently at imminent risk of self-harm - You have a history of certain substance use disorders - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

2 dosing sessions 1 week apart, each about 6-8 hours duration Psilocybin-assisted therapy (PAT), is a psychotherapeutic intervention in which the psychological effects of psilocybin play a significant role. PAT procedures typically involve psychological preparation prior to therapist-supported psilocybin dosing sessions. These sessions are used to establish a therapeutic relationship, inform participants about what to expect, and set expectations for the dosing session. During the psilocybin dosing session, trained therapists support the individual through their experience and psychological integration therapy occurs after the dosing experience. PAT has shown impressive antidepressant effects in people with TRD or severe MDD in at least six modern-era clinical trials (Andersen et al., 2021).