Psilocybin Versus Ketamine in Treatment-Resistant Depression (PSIKET_001)
Randomised, quadruple-blind Phase II parallel RCT (n=60) comparing single-dose oral psilocybin (25 mg) vs oral ketamine (250 mg) vs midazolam (5 mg) for treatment-resistant depression; primary outcome MADRS at 24 hours.
Details
Double-blind, randomised, parallel-group study in adults with treatment-resistant depression comparing single oral doses of psilocybin, ketamine and midazolam with primary endpoint MADRS at 24 hours.
Secondary outcomes assess duration of antidepressant effect (multiple MADRS and QIDS timepoints), response and remission rates, and time to initiation of standard antidepressant treatment over 12 weeks; safety is monitored throughout.
Exploratory measures include simultaneous EEG/fMRI to study functional brain-state changes, eye-tracking responses to emotional stimuli, and plasma biomarkers (BDNF, prolactin, ACTH, oxytocin) correlated with clinical outcomes.