Psilocybin – a strategy of rapid antidepressant response in depression comorbid with cancer, a randomized double-blind study with the possibility of entering open extension

Randomised, double-blind, phase II trial (n=60) comparing single supervised oral administrations of psilocybin, oral ketamine, and oral midazolam in patients with depressive disorder comorbid with cancer; non-responders are offered an open-label extension.

Primary outcome is change in MADRS at 4 weeks versus baseline; secondary outcomes include onset/duration of antidepressant effect (BECK, HAM-A, FACIT), safety/tolerability (AEs, vitals, BPRS, C-SSRS), and exploratory measures (5D-ASC, MEQ, PEQ) up to 24 weeks.