This open-label Phase IIa trial (n=64) evaluates the safety and tolerability of up to two doses of 5-MeO-DMT (BPL-003) in patients with treatment-resistant depression (TRD), for which some will receive SSRIs at the same time.
An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of one and two doses of intranasal BPL-003 combined with psychological support, in patients with treatment resistant depression when administered as monotherapy or as adjunctive therapy with defined SSRIs (citalopram, escitalopram, sertraline or fluoxetine).
BPL-003 arm mapping confirmed by reviewer: Arm A is the 10 mg intranasal cohort.
BPL-003 arm mapping confirmed by reviewer: Arm B is the 12 mg intranasal cohort.