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A phase 2 uncontrolled, open-label study of intranasal BPL-003 (5-methoxy- N,N -dimethyltryptamine) in patients with treatment-resistant depression

Claire T. Roberts, Mathieu Seynaeve, Anna O. Ermakova, Fiona Dunbar, Hattie Wells, Adeep Puri, Catherine Bird, James Rucker

Journal of Psychopharmacology February 27, 2026 DOI: 10.1177/02698811261420087 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Clinical trial Open-label Peer reviewed
Population Treatment-resistant depression (TRD) population
Intervention BPL-003
Duration 12 weeks
Topics Depression 5-MeO-DMT DMT
Keywords Depression economics Nasal administration Adverse effect Safety profile Phase matter Anesthesia Pharmacology
Key findings A single dose of BPL-003 produced a rapid and sustained reduction in MADRS score over 12 weeks in people with treatment-resistant depression.

Abstract

Results confirmed the safety profile of BPL-003 in a TRD population. A rapid and sustained reduction in MADRS score was observed over 12 weeks, suggesting BPL-003 could be beneficial in TRD, warranting investigation in larger controlled trials.

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