ISI

An open-label, dose-escalation trial of psilocybin-assisted therapy for bipolar 2 depression

In an open-label, single-arm dose-escalation pilot (n=14) of psilocybin-assisted therapy for bipolar II depression, psilocybin (10 mg, with 25 mg if needed) was generally well tolerated and produced significant, sustained reductions in depressive symptoms and improved quality of life up to 90 days, with adverse events (including transient anxiety, nausea, headache and three notable psychiatric events) broadly comparable to other psilocybin studies. The authors conclude that randomised, placebo-controlled trials are needed to confirm efficacy and refine dosing protocols in this vulnerable population.

Published

July 7, 2025

Journal

OSF Preprints

Authors

Downey, A. E., Szigeti, B., Bradley, E. R., Fernandes-Osterhold, G., Sakai, K., Llerena, K., Nerayo, J., Fredenburg, L., Nielsen, B., Krystal, A. D., O'donovan, A., Gard, D. E., Woolley, J. D.