Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression: The EPISODE Randomized Clinical Trial - PubMed
6 hours ago
- #Psilocybin
- #Treatment-Resistant Depression
- #Clinical Trial
- Psilocybin was studied for its efficacy and safety in treating treatment-resistant depression (TRD) in a randomized clinical trial.
- The trial involved 144 participants divided into groups receiving psilocybin (25 mg, 5 mg) or placebo (nicotinamide) with adjunct psychotherapy.
- Primary outcome (response rate at week 6) showed 17.0% response for 25 mg psilocybin vs. 10.6% for placebo, but results were not statistically significant.
- Secondary outcomes suggested a clinically meaningful reduction in depressive symptoms with 25 mg psilocybin.
- Adverse events, including suicidal ideation and hallucinogen persisting perception disorder, were reported with 25 mg psilocybin.
- The trial concluded that while psilocybin showed potential, results were inconclusive regarding primary efficacy.