An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
NCT ID: NCT04433858
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
27 participants
INTERVENTIONAL
2021-03-01
2026-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Psilocybin
25mg 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.
Psilocybin
open-label
Interventions
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Psilocybin
open-label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Note for CA site: Only Veterans are Eligible
18 Years
65 Years
ALL
No
Sponsors
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COMPASS Pathways
INDUSTRY
Sheppard Pratt Health System
OTHER
Responsible Party
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Scott T. Aaronson, M.D
Director, Clinical Research Programs
Principal Investigators
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Scott Aaronson, MD
Role: PRINCIPAL_INVESTIGATOR
Sheppard Pratt Health System
Locations
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VA Palo Alto Healthcare System/Stanford Medicine
Palo Alto, California, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
Countries
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References
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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.
Ellis 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.
Other Identifiers
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14947563
Identifier Type: -
Identifier Source: org_study_id
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