Open-label, single-arm Phase II multicentre study (n=6 actual) evaluating inhaled GH001 individualized dosing regimen (up to three escalating doses 6, 12, 18 mg in one day) in adults with bipolar II disorder experiencing a major depressive episode.
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.
Individualised inhaled dosing regimen (up to 3 escalating doses in a single day)
IDR: up to three escalating doses (6, 12, 18 mg) on same day; subsequent doses only if no peak experience.