From Amygdala to Synapse: A Multimodal Longitudinal RCT of Psilocybin-Assisted Therapy for Major Depressive Disorder Integrating Neuroplasticity Biomarkers, Inflammatory Indices, and Acute Experiential Mediators
2026 Irina Dell'Orto
Background: Psilocybin-assisted therapy (PAT) has demonstrated rapid and substantial antidepressant effects in phase 2 RCTs (Davis et al., 2021; Carhart-Harris et al., 2021), and phase 3 trials are now active (Usona uAspire, NCT06308653). However, three critical gaps remain unresolved in 2025: (1) the durability of effects beyond 12 months has not been established in a controlled design; (2)...