Study of Psilocybin Treatment with Different Post-Dose Supports for Adults Aged 18 to 70 With Depression

What this Trial Is About

Researchers are evaluating the effects of a single dose of psilocybin combined with psychological support on adults aged 18 to 70 who have experienced a major depressive episode lasting at least 60 days. The study also compares different post-dosing interventions, including a device called transcutaneous auricular Vagus Nerve Stimulation taVNS, to see how they affect psychological and behavioral outcomes. The trial aims to understand real-world social behavior and identify early responses linked to long-term results. All participants will receive one 25 mg dose of synthesized psilocybin under careful preparation and support, including preparatory sessions, facilitators during dosing, and post-dosing integration sessions. After dosing, participants are randomly assigned to one of three groups twice daily taVNS sessions for 7 days, twice daily sham taVNS sessions for 7 days, or no taVNS. The taVNS and sham sessions include music and guided reflections related to the psilocybin experience. Participants will undergo multiple assessments before and after dosing to measure depression, anxiety, well-being, quality of life, social roles, suicidal thoughts, and any adverse events. Data collection includes questionnaires and devices that record social behavior and experiences over several weeks. The main outcomes focus on depression scores, social participation, and quality of life, with follow-up assessments continuing up to 8 weeks post-dose to monitor effects and safety.

Investigation to Understand and Optimize Psilocybin