An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
1 other identifier
interventional
27
1 country
2
Brief Summary
The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2021
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedAugust 9, 2024
August 1, 2024
4.3 years
June 13, 2020
August 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Montgomery Asberg Depression Rating Scale (MADRS)
MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = \>50% decrease and Remission =\< 10 actual score.
From Baseline (Day -1) to three weeks post-dose.
Study Arms (1)
Psilocybin
EXPERIMENTAL25mg of Psilocybin Note: CA site only is re-dosing participants with an exacerbation in depressive symptoms at a minimum of 12 months post-initial dosing.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of at least moderate Major Depressive Disorder (MDD)
You may not qualify if:
- Comorbidities
- Note for CA site: Only Veterans are Eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheppard Pratt Health Systemlead
- COMPASS Pathwayscollaborator
Study Sites (2)
VA Palo Alto Healthcare System/Stanford Medicine
Palo Alto, California, 94304, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21204, United States
Related Publications (2)
Ellis S, Bostian C, Donnelly A, Feng W, Eisen K, Lean M, Conlan E, Ostacher M, Aaronson S, Suppes T. Long-term outcomes of single-dose psilocybin for U.S. military Veterans with severe treatment-resistant depression - 12-month data from an open-label pilot study. J Affect Disord. 2025 Nov 15;389:119655. doi: 10.1016/j.jad.2025.119655. Epub 2025 Jun 9.
PMID: 40499827DERIVEDEllis S, Bostian C, Feng W, Fischer E, Schwartz G, Eisen K, Lean M, Conlan E, Ostacher M, Aaronson S, Suppes T. Single-dose psilocybin for U.S. military Veterans with severe treatment-resistant depression - A first-in-kind open-label pilot study. J Affect Disord. 2025 Jan 15;369:381-389. doi: 10.1016/j.jad.2024.09.133. Epub 2024 Sep 27.
PMID: 39343309DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Aaronson, MD
Sheppard Pratt Health System
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Research Programs
Study Record Dates
First Submitted
June 13, 2020
First Posted
June 16, 2020
Study Start
March 1, 2021
Primary Completion
June 1, 2025
Study Completion
May 1, 2026
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share