This open-label Phase II trial (n=100) will study the safety, tolerability, and potential therapeutic effects of psilocybin (2 x 25 mg oral doses, taken at least 3 weeks apart) in the biological children of genocide survivors who are living with mood and anxiety disorders.
Open-label, single-group Phase II study testing two supervised 25 mg oral doses of psilocybin given 3–4 weeks apart alongside preparatory and integration therapy in adult biological children of genocide survivors with depressive or anxiety disorders.
Primary aims are to assess safety and tolerability; secondary aims include changes in depression, anxiety, stress, psychological resilience, and effects related to parental exposure to genocide. Assessments include clinical scales and biomarker collection across screening, treatment, and follow-up.
Participants receive three preparatory sessions, two dosing days, and six integration sessions (three after each dose), with monitoring and safety checks including supervised tapering of prohibited medications when necessary.
Two supervised 25 mg psilocybin doses with preparatory and integration therapy.
Two 25 mg capsules administered 3–4 weeks apart under supervision of two trained clinicians.
Preparatory and integration therapy: three preparatory sessions; three weekly integration sessions after each dose (6 total).