An open-label, dose-escalation trial of psilocybin-assisted therapy for bipolar 2 depression
July 7, 2025 Balazs Szigeti preprint
Psilocybin therapy under controlled conditions appears safe and potentially effective for reducing depressive symptoms and improving quality of life in individuals with bipolar II disorder experiencing moderate-to-severe depression. In an open-label pilot trial, 14 participants received 10 mg of psilocybin, followed by 25 mg if symptoms persisted, alongside psychotherapy. No serious adverse events occurred; common effects included mild-to-moderate anxiety, nausea, and headache. Three participants experienced suicidal ideation or hypomania, which resolved with support. Depression scores improved at all timepoints, with a 21-day reduction of 12.7 points after 10 mg and 18.6 after 25 mg. Quality of life also improved at 90 days. Feared outcomes like mania, psychosis, and suicidality were not elevated relative to other clinical populations treated with psilocybin.