A Phase 3 Randomized Double-Blind Multicenter Study to Evaluate the Efficacy Safety and Tolerability of Psilocybin in Adults with Major Depressive Disorder
The purpose of this research study is to see if the investigational drug, psilocybin, can help people with major depressive disorder (MDD). This clinical trial s designed to evaluate the safety and efficacy of psilocybin 25 mg versus placebo in adult participants with major depressive disorder (MDD) who are experiencing a depressive episode of at least a 60-day duration. Participants will be randomly assigned to receive a single oral dose of psilocybin 25 mg, psilocybin 5 mg, or inactive placebo, administered with psychosocial support.
A Phase 2b Randomized Double-blind Placebo-controlled Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer
This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (anxiety, depression) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with late-stage or advanced cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center RCT comparing a single 25mg oral ‘high’ dose of psilocybin to a single 100mg dose of niacin (active placebo), both delivered in conjunction with a psychotherapy platform.