12-month follow-up study of psilocybin for treatment-resistant depression in Japan: long-term safety, efficacy, MRI and TMS-EEG

Psilocybin therapy for treatment-resistant depression is being followed up for 12 months to assess long-term safety and efficacy. The study focuses on participants who completed a prior single-arm open-label trial and aims to evaluate depressive symptom outcomes using measures such as MADRS as the primary endpoint, with additional scales including HDRS, QIDS-SR, and C-SSRS. The protocol includes multimodal exploratory assessments using MRI and TMS-EEG to investigate the site of action possibility, track neurological changes, and search for biomarkers associated with long-term treatment effects.