5 Key Takeaways

• 1

  A phase 2b trial found psilocybin-assisted psychotherapy did not significantly improve response rates in treatment-resistant depression at 6 weeks.

• 2

  Response rates were 17% for psilocybin 25 mg, 13% for psilocybin 5 mg, and 11% for nicotinamide, failing to meet the primary endpoint.

• 3

  Exploratory analyses indicated greater reductions in depressive symptoms with psilocybin 25 mg, particularly noted at 1 week.

• 4

  Methodological challenges, including functional unblinding, complicate the interpretation of results and the role of expectancy effects.

• 5

  Adverse events were common, with increased suicidal ideation in the psilocybin 25 mg group, highlighting safety concerns.