| Registry | NCT04433858 |
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| Status | Unknown |
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| Phase | Phase 2 |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 27 (Actual) |
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| Sponsor | Sheppard Pratt Health System (Other); collaborators: COMPASS Pathways |
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| Conditions | Treatment Resistant Depression |
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| Interventions | Psilocybin (Drug) |
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| Dates | start 2021-03-01, primary completion 2025-06-01 (estimated), completion 2026-05-01 (estimated), first posted 2020-06-16, last updated 2024-08-09 |
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| Locations | 2 sites in United States |
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All trials for Treatment Resistant Depression All trials of Psilocybin
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Psilocybin | Experimental | Drug: 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 (Drug), also known as COMP360: open-label
+Outcome measures
Primary outcomes
- Montgomery Asberg Depression Rating Scale (MADRS) [From Baseline (Day -1) to three weeks post-dose.]: 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.
+Eligibility
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria:
* Diagnosis of at least moderate Major Depressive Disorder (MDD)
Exclusion Criteria:
* Comorbidities
Note for CA site: Only Veterans are Eligible
+Locations (2)
| Facility | City | Country | Status |
|---|
| VA Palo Alto Healthcare System/Stanford Medicine | Palo Alto, California | United States | |
| Sheppard Pratt Health System | Baltimore, Maryland | United States | |
+Publications
- Results publication: Kelly CM, Fradet M, Bostian CM, Donnelly A, Ellis S, Ostacher M, Aaronson S, Suppes T. Changes in anxiety, quality of life, and functioning following psilocybin-assisted therapy in veterans with treatment-resistant depression. J Affect Disord. 2026 Nov 1;412:122063. doi: 10.1016/j.jad.2026.122063. Epub 2026 Jun 4. PMID 42248535
- Results publication: 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 40499827
- Results publication: Aaronson ST, van der Vaart A, Miller T, LaPratt J, Swartz K, Shoultz A, Lauterbach M, Suppes T, Sackeim HA. Single-Dose Psilocybin for Depression With Severe Treatment Resistance: An Open-Label Trial. Am J Psychiatry. 2025 Jan 1;182(1):104-113. doi: 10.1176/appi.ajp.20231063. PMID 39741440
- Results publication: 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. PMID 39343309
+Investigators