A phase II randomized, double-blind, active placebo-controlled parallel group trial to examine the efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE)
Randomized, double-blind, parallel-group Phase II trial (n=144) comparing 25 mg psilocybin vs 5 mg psilocybin (low-dose active placebo) vs nicotinamide 100 mg in adults (25–65) with treatment-resistant major depression, delivered with psychotherapy.
Details
EPIsoDE is a Phase II randomized, double-blind, active placebo-controlled parallel-group trial assessing the efficacy and safety of a single 25 mg oral psilocybin dose compared with a 5 mg low psilocybin dose and 100 mg nicotinamide in adults with treatment-resistant major depression, delivered within a psychotherapeutic framework.
Primary outcome is responder rate (≥50% reduction in HAM-D) at six weeks after first dose; secondary outcomes include BDI-II, remitter rates, additional responder analyses at 1 week, 12 weeks and follow-ups at 6 and 12 months, plus safety measures (vitals, ECG, labs, C-SSRS, UKU, DSS-4, AEs/SAEs).