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.
Led by Dr Rachel Yehuda at the Icahn School of Medicine at Mount Sinai, this study aims to address the impact of intergenerational trauma—a psychological phenomenon where the effects of extreme parental stress (such as surviving a genocide) are carried into the next generation.
Participants will undergo two psilocybin-assisted therapy sessions, each supervised by trained clinicians, alongside multiple preparatory and integration (post-treatment) therapy sessions. The researchers aim to examine changes in depression, anxiety, stress, and resilience, as well as how participants relate to their parents’ trauma. Safety is a primary concern, with measures like the Columbia-Suicide Severity Rating Scale (C-SSRS) used throughout the study. This is the first known trial to explore psilocybin’s effects in the context of inherited trauma, and could inform new, culturally sensitive treatments for communities affected by historical atrocities.
Trial Details
This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.Trial Number NCT06899165
Sponsors & Collaborators
Icahn School of Medicine at Mount SinaiThis company doesn't have a full profile yet, it is linked to a clinical trial.