Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression
Non-randomised, single-group Phase II trial (n=10) assessing safety and acceptability of up to two 25 mg oral psilocybin administrations with therapeutic support in individuals with Bipolar II depression and suicidal ideation (second dose optional, 4 weeks apart).
Details
This single-group, open-label Phase II study will evaluate the safety, feasibility and acceptability of up to two 25 mg oral psilocybin administrations given 4 weeks apart alongside structured therapeutic support in adults with Bipolar II depression and suicidal ideation (without active plan or intent).
Therapeutic support follows a mindfulness-based CBT approach with five preparatory sessions before the first administration, an optional 60-minute preparation before a second administration, and three integration sessions after each dosing session; additional optional therapy is available during the trial.
Outcomes include measures of suicidality, depressive symptoms, and acute subjective experiences using validated instruments (INQ, MADRS, C-SSRS and others), with safety monitoring via clinical and laboratory assessments.