Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder (PAT-BD-01)
This randomised, quadruple-blind, placebo-controlled Phase III trial (n=90) will study the effectiveness, safety, and tolerability of psilocybin (25 mg)–assisted therapy compared to an active placebo (1 mg psilocybin) in individuals with treatment-resistant depression associated with bipolar II disorder.
Details
Randomised, quadruple-masked, parallel-group Phase III trial (n=90) assessing single-dose psilocybin 25 mg assisted therapy versus a 1 mg active placebo in adults with treatment-resistant bipolar II depression; primary objective is effectiveness, safety and tolerability over 12 weeks.
Participants have up to 30 days of screening and ~12 weeks of follow-up (11 study visits over ~16 weeks), including five therapy sessions delivered by trained study therapists; key exclusions include history of psychosis, seizures, recent psychedelic use, unstable medical illness, and pregnancy.