BPL-003 Efficacy and Safety in Treatment Resistant Depression

This quadruple-masked, randomised, multi-centre Phase II study (n=225) investigates the efficacy and safety of a single intranasal dose of BPL-003, combined with psychological support, in patients with treatment-resistant depression (TRD).

The trial, initiated on September 14, 2023, is scheduled for completion in December 2024. Participants will be divided into low, medium, and high dose groups, with psychological support provided before, during, and after dosing. The primary outcome measure is the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) after 4 weeks, assessing the severity of depressive episodes. Secondary outcome measures include safety assessments, suicidal ideation, and plasma levels of 5-MeO-DMT and its metabolites.

Beckley Psytech Ltd is the sponsor, and the study involves various locations in the United States, Australia, Germany, Poland, and Spain. The study aims to address the pressing issue of TRD and contribute valuable insights to treatment approaches for depression.

Trial Details

This is a Phase II study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

NCT Number NCT05870540

Data attribution

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