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Psilocybin for Treatment-Resistant Depression in Autism

Study acronym: PAT-DA
StatusActive, Not Recruiting
PhasePhase 1
Started2024-11-01
View on ClinicalTrials.gov ↗

Amendment history

2026-08-04
Study Status, Contacts/Locations v4
Enrollment closed, study ongoing
Primary completion moved earlier: 2027-08 → 2026-12
Completion moved earlier: 2027-08 → 2026-12
Study sitesdetails revised at 1 of 1 site
2026-03-18
Study Status v3
Re-verified, no change to tracked fields
2026-01-27
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v2
Eligibility criteria+520 characters
Inclusion Criteria: AutisticMust adult,be agesaged 18- to 65 years old; Must be deemed to have capacity to provide informed consent; Ability to read and communicate in English; Must sign and date the informed consent form; Stated willing [...] ndardized intelligence scales, or 2) the participant scores >>10 percentile on the nine-item form of the Raven's Standard Progressive Matrices Test (RSPM). AbilityClinical todiagnosis readof andautism communicatespectrum indisorder English(ASD), suchbased that their literacy and comprehension is sufficient for understandingon the consentDSM-5 formor and stud [...] [...]
Secondary endpoints3 to 2 entries
Subjective Psychedelic Effects as Measured by the 11-Dimensions of Altered States of Consciousness (11D-ASC) Rating Scale
Primary endpoints3 to 4 entries
Subjective Psychedelic Effects as Measured by the 11-Dimensions of Altered States of Consciousness (11D-ASC) Rating Scale
Study description+3,504 characters
Each participant will begin with a screening visit (V1), during which eligibility will be determined through clinical and psychiatric assessments of the participant's physical and mental health. Following confirmation of eligibility, the study procedures will begin. The participant will begin with a [...]
Study title-71 characters
Psilocybin for Treatment-Resistant Depression in Autism With Pre-Post Brain and Cognitive Measurement to Understand Mechanisms
2025-02-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12→confirmed 2024-11-01
Study sitesdetails revised at 1 of 1 site
2024-12-09
Original filing
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 Details
NCT Number NCT06731621
Lead Sponsor Centre for Addiction and Mental Health
Conditions Treatment Resistant Depression, Autism Spectrum Disorder
Enrollment 20 participants
Start Date 2024-11-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-06