Randomised, quadruple‑blind, active‑placebo controlled Phase II trial (n=100) comparing a single 25 mg oral dose of psilocybin to 1 mg in patients with cancer‑related MDD (age 20–80).
This randomised, parallel‑group, quadruple‑blind study randomises participants 2:1 to a single oral 25 mg dose of psilocybin or an active placebo (1 mg) to evaluate antidepressant efficacy in cancer‑related major depressive disorder.
Primary outcome is change in depressive symptoms; participants undergo preparatory and follow‑up sessions, safety monitoring including ECG and labs, and must abstain from other psychotherapies or antidepressants during the study period.
Single oral 25 mg psilocybin dose
Active placebo 1 mg psilocybin
Randomisation 2:1 (25 mg : 1 mg)