A Study of Psilocybin for Major Depressive Disorder (MDD)
Double-blind, randomised, parallel-group Phase II study (n=104 actual) comparing a single 25 mg oral dose of psilocybin to a single 100 mg oral dose of niacin (active placebo) in participants with MDD, assessed to Day 43 post-dose.
Details
Randomised, triple-masked, parallel-group trial enrolling adults 21–65 with DSM-5 major depressive disorder to compare a single 25 mg oral dose of synthetic psilocybin versus 100 mg oral niacin (active placebo). Participants receive identical Set and Setting (SaS) procedures.
The SaS protocol includes preparatory meetings with facilitators, an extended supervised dosing session (typically several hours), and post-dose integration sessions. Primary outcome is change in depressive symptoms from baseline to Day 43; safety and tolerability are also assessed.