A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
102actual
Sites
5
Country
United States
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 | 2023-01-30 | actual | When the study began enrolling |
| Primary completion | Sep 2025 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2025 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Major Depressive Disorder
Intervention
- Drug: Psilocybin — also filed as COMP360
Primary outcome
what the primary-completion date above is the date OFSafety and tolerability of COMP360 Psilocybin
measured Up to Week 6
Publications
- PMID 40375477 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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