The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density
The effect of psilocybin on major depressive disorder (MDD) symptom severity and synaptic density - a single dose randomized, double blind, placebo-controlled Phase IIb positron emission tomography study.
Details
Randomized, double-blind, parallel-group Phase 2b trial (n=35 actual) comparing a single 25 mg oral dose of psilocybin with a single 100 mg niacin active placebo in adults with MDD; primary outcome is change in MADRS score to Day 8.
Participants undergo MRI and PET with [11C]UCB-J to assess synaptic density at baseline and Day 15; one preparation session and three post-dose integration sessions are provided under a set-and-setting protocol with two facilitators present during dosing.
Safety measures and biological samples (CSF, blood) collected at baseline and Day 15; follow-up visits continue to Day 365 for clinical outcomes and safety.