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The Antidepressant Effects of Vaporized N,N-Dimethyltryptamine: An Open-Label Pilot Trial in Treatment-Resistant Depression.

Marcelo Falchi-Carvalho, Handersson Barros, Raynara Bolcont, Sophie Laborde, Isabel Wießner, Sérgio Ruschi B Silva, Daniel Montanini, David C Barbosa, Ewerton Teixeira, Rodrigo Florence-Vilela, Raissa Almeida, Rosana K. A. de Macedo, Flávia Arichelle, Érica J. Pantrigo, José V Costa-Macedo, Emerson Arcoverde, Nicole Galvão-Coelho, Draulio B Araujo, Fernanda Palhano-Fontes

Psychedelic Medicine March 1, 2025 DOI: 10.1089/psymed.2024.0002 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Open-label clinical trial Pilot study Peer reviewed
Sample size 6
Population Patients with treatment-resistant depression
Intervention Vaporized DMT
Dose 15 mg then 60 mg
Duration Single-day session with follow-up up to one month
Topics 5-MeO-DMT Depression DMT
Keywords N,N-Dimethyltryptamine Psychedelics DMT Hallucinogens Entheogens Mental health depression Mood disorders Psychological disorders
Citations 16
Registration NCT06094907
Key findings Vaporized DMT produced rapid and sustained antidepressant effects, with 83.33% of patients responding by day 7 and 66.67% maintaining response at one month.

Abstract

N,N-Dimethyltryptamine (DMT), a naturally occurring psychedelic tryptamine contained in the indigenous ayahuasca brew, has shown antidepressant effects. This open-label clinical trial investigates for the first time the efficacy of vaporized DMT in treatment-resistant depression (TRD). Six TRD patients participated in an open-label, fixed-order, dose-escalation study, receiving a lower (15 mg) and then a higher (60 mg) dose of vaporized DMT in a single-day session. Depression severity was assessed using the Montgomery-Asberg depression rating scale (MADRS) and the Patient Health Questionnaire-9 (PHQ-9) up to one month post-dosing. Significant reductions in MADRS and PHQ-9 scores were noted from Day 1 to Month 1 (M1). The mean MADRS score variation from baseline to Day 7 (D7) was -22 points and -17 points at M1. PHQ-9 scores also showed significant decreases, mirroring the MADRS results. By D7, 83.33% of patients responded to treatment, with 66.67% achieving remission. At M1, 66.67% maintained response, and 50% maintained remission. The rapid onset and sustained antidepressant effects of vaporized DMT align with the paradigm of rapid-acting antidepressants to be used in the scope of interventional psychiatry. The noninvasive route and short-acting nature of DMT offer practical advantages, potentially enhancing accessibility to psychedelic treatments.Clinical Trial Registration: Clinicaltrials.gov NCT06094907.

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

    Vaporized DMT (15 mg then 60 mg) produced significant MADRS and PHQ-9 reductions from day 1 to month 1, with 83.33% responding by day 7 and 66.67% maintaining response at one month.

    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: 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
Beyond symptom reduction: DMT improves anxiety, life satisfaction, and quality of life in healthy volunteers and patients with depression Healthy individuals and patients with treatment-resistant depression 2026 Open-label clinical trial n = 41

Citations in the library

Cited by 14

and 9 more in the library

Cites 13

and 8 more in the library

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5-MeO-DMT Depression DMT Ayahuasca

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