Psilocybin versus ketamine – fast acting antidepressant strategies in treatment-resistant depression
Randomised, double‑blind, parallel group Phase II trial (n=60) comparing a single oral dose of psilocybin 25 mg versus ketamine 250 mg and midazolam 5 mg in patients with treatment‑resistant depression, primary endpoint MADRS at 24 hours.
Details
A single‑site, randomised, double‑blind, parallel group trial enrolling 60 patients with treatment‑resistant moderate to severe depression to compare rapid antidepressant effects of psilocybin (25 mg), ketamine hydrochloride (250 mg) and an antidepressant‑inactive midazolam control (5 mg), assessed primarily by MADRS at 24 hours.
Secondary outcomes include duration of antidepressant effect at multiple timepoints up to 12 weeks (MADRS, QIDS), response and remission rates, time to relapse, and safety measures including vital signs, BPRS, psilocin levels and persistent effects scales.