This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation.
Open-label, single-group Phase II study (n=20) assessing a single 25 mg oral dose of psilocybin with supportive psychological care in adults with treatment-resistant depression and chronic suicidal ideation.
Primary aims are safety and tolerability; assessments include adverse events, measures of suicidality and depressive symptoms, and standard clinical safety monitoring.
Key eligibility includes MDD with active suicidal ideation without immediate intent and failure to respond to at least two medications. Sponsor and site: Sheppard Pratt Health System, Baltimore, MD, USA.
Single-group open-label 25 mg psilocybin
Open-label, single 25 mg dose with supportive psychological care