Psilocybin for Major Depressive Disorder

The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.

Inclusion Criteria:Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severityAged 18-85Ability and willingness to attend study visits and complete study assessmentsExclusion Criteria:Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT > 150, QTc > 450ms, MELD > 9)Depression deemed secondary to a severe medical conditionRecent use of any classical psychedelic drug or MDMARecent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS)Intention to begin any new treatment for depression prior to primary outcome determinationUse of any excluded medicationActive substance use disorderPresence of any psychiatric condition that may interfere with the safe administration of psilocybinActive suicidal ideation