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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)

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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.

In the evidence

This study is part of the evidence base for a synthesis in the library. Here is how each one recorded it.

  • State of the evidence: DMT for depression Supports

    A single dose of intranasal BPL-003 produced a rapid and sustained reduction in MADRS score over 12 weeks in people with treatment-resistant depression.

    Synthesized

Comparable studies

Other non-randomized and open-label trials on DMT for depression, most cited first.

Study Year Design Participants
Exploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder. Treatment-resistant individuals with major depressive disorder (MDD) and healthy controls 2022 Open-label, fixed-order, dose-escalation exploratory phase 1 study n = 10
A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression Adult patients with treatment-resistant depression 2023 Phase 1/2 clinical trial n = 16
Rapid and sustained antidepressant effects of vaporized N,N-dimethyltryptamine: a phase 2a clinical trial in treatment-resistant depression. Patients with treatment-resistant depression 2025 Open-label trial n = 14
The Antidepressant Effects of Vaporized N,N-Dimethyltryptamine: An Open-Label Pilot Trial in Treatment-Resistant Depression. Patients with treatment-resistant depression 2025 Open-label clinical trial n = 6
The antidepressant effects of vaporized N,N-Dimethyltryptamine: a preliminary report in treatment-resistant depression Patients with treatment-resistant depression 2024 Open-label, fixed-order, dose-escalation study (Phase 2a clinical trial) n = 6

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