Safety and Acceptability of Two Psilocybin Doses with Therapy for Bipolar II Depression and Suicidal Thoughts

What this Trial Is About

Researchers are evaluating the safety and acceptability of up to two doses of 25 mg psilocybin combined with psychological support to reduce suicidality in adults with Bipolar II depression who experience suicidal thoughts without active plans. This Phase 2 clinical trial aims to explore whether psilocybin with therapy is a feasible and acceptable treatment option, addressing a critical need for effective suicidality treatments in this population. Participants will receive up to two psilocybin doses spaced four weeks apart, along with therapeutic support based on mindfulness-based cognitive behavioral therapy and psychedelic treatment principles. Before the first dose, five preparatory in-person psychotherapy sessions occur weekly, with a shorter session before the optional second dose. Each psilocybin session is followed by three integration therapy sessions, and additional therapy is available throughout the trial if desired. During the study, participants will complete assessments of suicidality, depression, mania, and psychiatric symptoms using validated questionnaires at baseline and several weeks after dosing. Researchers will monitor participation through therapy attendance and assessment completion to evaluate feasibility and acceptability. Safety and psychological effects will be closely tracked, with the study lasting up to 11 weeks after the first psilocybin session.

Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality