Psilocybin and Depression
Randomized, double-blind, parallel Phase II trial (n=60) comparing a single oral 25 mg psilocybin dose, intranasal 125 mg ketamine, and a no-treatment group in participants with severe major depressive disorder; outcomes include depression severity and fMRI biomarkers.
Details
This randomized, double-blind, parallel study (n=60) compares single-dose psilocybin (25 mg, oral) with intranasal ketamine (125 mg) and a no-treatment group in participants with moderate-to-severe major depressive disorder.
Depression severity is assessed at baseline and at 1 week, 3 months and 6 months after dosing. Functional MRI is performed before and one week after administration to identify brain-network changes associated with clinical response.
Blood samples are collected to investigate gene expression and molecular correlates of rapid antidepressant effects and to explore biomarkers predictive of outcome.