COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Depression Trial
Two supervised doses produced a highly significant MADRS drop in treatment-resistant depression.
Compass Pathways said COMP360, a synthetic pharmaceutical psilocybin, met the primary endpoint of COMP006, the second of two Phase 3 trials in treatment-resistant depression.
Two 25 mg doses given three weeks apart produced a highly statistically significant reduction in MADRS scores versus 1 mg (P<0.001) and a clinically meaningful 3.8-point difference at week 6. Earlier COMP005 data suggested participants who improved maintained effect through at least week 26 after one or two doses.
This is not recreational use. It is a regulated, clinic-administered programme for people who have already failed standard antidepressants.
Key Facts
- Primary endpoint met: MADRS change at week 6, 25 mg vs 1 mg, P<0.001
- Clinically meaningful difference: -3.8 points
- Two doses, three weeks apart
- Durability signal from COMP005 through week 26
Why This Matters
Treatment-resistant depression affects millions who have already failed standard antidepressants. A second positive Phase 3 is the evidence bar the field has been missing.
What We Don't Know Yet
Expectancy and functional unblinding are hard to eliminate in psychedelic trials. The therapy requires specialised clinics, not a GP prescription. Long-term real-world safety and access remain open.
Sources: Psychiatric Times
Published 21 September 2026 · Category: Health & Medicine