SPL026 With or Without SSRIs in Participants With MDD

This Phase I, non-randomised, parallel-cohort study compares patients on a stable SSRI (Test Cohort) with patients not on antidepressants (Control Cohort); all participants receive a single intravenous infusion of SPL026 (DMT fumarate) to assess safety and tolerability.

Primary outcomes focus on safety and tolerability via vitals, ECG, labs and adverse events; eligibility excludes recent psychedelic use, MAOI antidepressants, significant medical/psychiatric comorbidity, and significant suicide risk.