Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

Multicentre, open-label, single-group Phase II trial of inhaled GH001 (5-MeO-DMT) in adults with bipolar II depression. Participants receive an individualized dosing regimen (IDR) of up to three escalating inhaled doses (6 mg, 12 mg, 18 mg) administered on a single day.

Primary purpose is treatment; dosing escalates within-session until a peak experience is achieved. Safety, tolerability and depressive symptom change are assessed per protocol across follow-up visits.