A Double-Blind Randomised Controlled Trial of the Efficacy of Microdosing with Psilocybin to treat Moderate Depression

This is a double-blind, randomised, parallel-group Phase II trial assessing low-dose oral psilocybin (WP001) taken onsite 11 times over six weeks (every 3–4 days) in participants with moderate major depressive disorder; the active comparator arm receives caffeine 60 mg in identical capsules.

Participants are monitored by a psychiatrist throughout; dosing may be titrated down to 2 mg for safety. A nested neuroimaging (MEG) substudy will recruit up to 80 participants (baseline and first-dose scan), with every third participant invited to participate.