An Open-Label, Dose-Escalation Trial of Psilocybin-Assisted Therapy for Bipolar II Depression.
J Clin PsychiatrySep 21, 2026 (epub)
Clinical ResearchPsychiatry
Amanda E Downey, Balázs Szigeti, Ellen R Bradley et al.
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In 30 seconds
This open-label, single-arm pilot trial evaluated the safety, tolerability, and preliminary efficacy of psilocybin therapy in 14 individuals with bipolar II disorder (BD-II) and depression. Results indicated significant improvements in depression scores, with a reduction of -12.7 after 10 mg and -18.6 after 25 mg of psilocybin, both with P <.001. Four participants achieved remission after the initial dose.
Key findings
- MADRS scores improved significantly by -12.7 after 10 mg of psilocybin (P <.001).
- Among those receiving 25 mg, MADRS scores improved by -18.6 (P <.001) 21 days post-administration.
- Quality of Life in Bipolar Disorder scores improved by 31.2 at 90 days after the final dose (P =.004).
- Psilocybin was well tolerated with no serious adverse events reported.
Why it matters
The study highlights a potential new treatment avenue for individuals with BD-II and depression, a population often excluded from existing therapies. Understanding the safety and preliminary efficacy of psilocybin could inform future treatment strategies.