Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans

This fixed-order, open-label study administers two IV doses of DMT (0.1 mg/kg then 0.3 mg/kg) across two test days in healthy volunteers and participants with major depressive disorder to characterise safety and inform dosing for a subsequent double-blind, randomized, placebo-controlled crossover trial.

Neuroplastic and mood-related effects will be indexed using EEG measures and psychometric assessments; outcomes will guide dose selection for future efficacy studies.