Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression
Randomised, triple-blind, active placebo-controlled Phase II study (n=144) comparing oral psilocybin 25 mg and 5 mg versus nicotinamide placebo in patients with treatment-resistant major depression, two dosing sessions with psychotherapeutic support.
Details
Multi-centre, randomized, parallel-group trial evaluating safety and efficacy of oral psilocybin (25 mg and 5 mg) versus nicotinamide 100 mg active placebo in adults with treatment-resistant major depression; two dosing sessions spaced six weeks apart.
Dosing is delivered under structured psychotherapeutic conditions with three preparatory and four integration sessions; participants remain hospitalised overnight after each dosing for monitoring. Outcomes include depressive symptoms (HAM-D), safety labs, ECG, and adverse events.