Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression (Psilo-BD)

This single-arm, open-label trial will give all participants one 25 mg oral dose of psilocybin paired with preparatory, monitoring and integration psychotherapy to assess neurobiological and clinical effects in treatment-resistant bipolar depression (BD-II).

Primary outcome examines the association between right amygdala activity on the facial affect fMRI one day after dosing and antidepressant response measured by change in MADRS over the first week; additional fMRI is at one month.