Safety and Efficacy of Psilocybin During Anticancer Treatment: A Phase II Trial Secondary Analysis.
J Pain Symptom ManageAug 3, 2026 (epub)
Daniel A Schaefer, Manish Agrawal, Emanuele Mazzola et al.
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In 30 seconds
This phase II trial secondary analysis evaluated the safety and efficacy of psilocybin-assisted therapy in cancer patients with major depressive disorder, comparing those receiving systemic anticancer treatment to those who were not. Results showed no significant differences in Montgomery-Åsberg Depression Rating Scale (MADRS) scores between groups at weeks 1, 3, and 8, indicating comparable antidepressant effects.
Key findings
- MADRS scores decreased significantly in both groups with no significant between-group differences at week 1 (P = .88), week 3 (P = .93), or week 8 (P = .97).
- Adverse events were frequent, with a mean of 9.0 in the systemic treatment group versus 6.7 in the non-treatment group (P = .08).
- Four severe adverse events occurred in the systemic treatment group, but were deemed unrelated to psilocybin.
Why it matters
The findings suggest that psilocybin-assisted therapy can be safely administered to cancer patients undergoing systemic treatment, potentially expanding treatment options for depression in this vulnerable population.