Fixed-order, open-label, dose-escalation interventional study (n=30 estimated) testing two IV DMT doses (0.1 mg/kg and 0.3 mg/kg) in healthy and depressed participants to assess safety and dose-related neurophysiological effects.
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.
0.1 mg/kg DMT intravenous fixed-order test day.
Low dose (0.1 mg/kg) administered IV on test day 1.
0.3 mg/kg DMT intravenous fixed-order test day.
Moderate dose (0.3 mg/kg) administered IV on test day 2.