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.
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.
Single oral 25 mg psilocybin under supervised conditions.
Single oral 25 mg psilocybin.
Single intranasal 125 mg ketamine under supervised conditions.
Intranasal administration (125 mg).
No-treatment comparator; assessments only.
No treatment — assessments only; remote follow-up for symptom ratings.