Investigational
Clinical Trials / State Regulated
Psilocybin-Assisted Therapy
Psilocybin, a naturally occurring psychedelic compound, is under rigorous clinical investigation for its profound ability to treat severe depression when combined with specialized psychotherapy.
Current Status
At the federal level, psilocybin remains a Schedule I controlled substance. It is only available legally through FDA-approved clinical trials. However, states like Oregon and Colorado have passed legislation to create regulated frameworks for legal, supervised access outside of the medical system.
Clinical Efficacy
The Data: Phase II/III Trials
- Treatment-Resistant Depression (TRD): Phase II trials (e.g., COMPASS Pathways) show that a single large dose of synthetic psilocybin, administered with psychological support, produces rapid and sustained antidepressant effects.
- Major Depressive Disorder (MDD): Johns Hopkins researchers found that two doses of psilocybin with psychotherapy produced large, rapid, and sustained antidepressant effects, with ~54% of participants in remission at 4 weeks.