Open-label Phase II single-group study (n=14) assessing ascending inhaled DMT (15 mg then 60 mg on a single day) for patients with partial response in depression.
This phase II, open-label, single-group fixed-order study evaluates feasibility, safety and antidepressant effects of inhaled N,N‑Dimethyltryptamine (DMT) in patients with partial response to depression treatment.
Participants receive up to two inhaled DMT doses in one day (15 mg then 60 mg, ~1 hour apart) delivered via a vapour device; outcomes include acute and subacute mood measures and safety assessments with cardiovascular and respiratory exclusions applied.
Ascending fixed-order inhaled DMT administered using a vaporiser: 15 mg then 60 mg separated by ~1 hour within a single day.
Vapour device; fixed-order 15 mg then 60 mg with ~1-hour interval.