Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
572actual
Sites
116
Countries
Canada, Czechia, Denmark +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-02-14 | actual | When the study began enrolling |
| Primary completion | 2025-11-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Treatment Resistant Depression
Intervention
- Drug: Psilocybin — also filed as COMP360
Primary outcome
what the primary-completion date above is the date OFCOMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score.
measured Week 6
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