Psilocybin-Assisted Therapy in Treatment-Resistant Depression

Randomized, parallel-group study comparing a single 25 mg psilocybin session to two 25 mg sessions spaced two weeks apart in adults with treatment-resistant major depressive disorder; all participants receive preparatory and integration psychotherapy.

Outcomes include change in depressive symptoms over 12 months, durability of response, safety and tolerability. Participants undergo screening, preparation visits, dosing sessions, and follow-up assessments over one year.