Key Takeaways
Extended Takeaways
- In the prespecified analysis of all COMP 001 participants, median time to depression-related event was 92 days (49–199) with 25 mg, 83 days (39–142) with 10 mg, and 62 days (28–NE) with 1 mg, suggesting a dose-related separation in durability even though formal significance testing was not performed.
- Among COMP 001 completers who entered the follow-up study, new antidepressant treatment had already been started by week 12 in 27.3% (n=6) of the 25 mg group, 47.4% (n=9) of the 10 mg group, and 58.8% (n=10) of the 1 mg group, which may help clinicians frame how often additional treatment is needed within 3 months after psilocybin.
- By Week 52, the proportion starting a new antidepressant treatment was 54.5% [n=12] in the 25 mg group and 57.9% [n=11] in the 10 mg group, while the 1 mg group was numerically greater at 76.5% (n=13), supporting the view that the 25 mg dose may delay rather than eliminate the need for subsequent depression treatment.
- The most common depression-related events were initiation of new antidepressant treatment and worsening MADRS total scores, whereas more acute markers such as hospitalization, suicide attempt, or discontinuation for lack of efficacy were less prominent; this makes time to treatment change a practical long-term outcome to monitor after psilocybin.
- Long-term safety signals were limited after week 12: 61 TEAEs occurred in 27 participants, the most common was COVID-19 in 13.8% (n = 8), and 4 TESAEs in 3 participants were all judged unrelated to study drug, including suicidal ideation requiring hospitalization on Study Day 307 in 1 participant in the 25 mg group.
- Interpretation should be cautious because only 58 (46%) of the 126 COMP 001 completers who were offered COMP 004 consented, and 31.8% of participants from COMP 001 were censored at study completion in the primary time-to-event analysis, creating substantial potential for selection bias in the longer-term estimates.
