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 (New Rochelle, N.Y.) March 1, 2025 DOI: 10.1089/psymed.2024.0002 via PubMed
Summary
AI-generated from the abstractVaporized N,N-dimethyltryptamine (DMT) produced rapid and sustained antidepressant effects in a small open-label trial of six people with treatment-resistant depression. Depression severity, measured by the Montgomery-Asberg depression rating scale (MADRS) and Patient Health Questionnaire-9 (PHQ-9), decreased significantly from the first day through one month after dosing. The average MADRS score dropped by 22 points at day 7 and 17 points at one month. By day 7, 83.33% of patients responded to treatment and 66.67% achieved remission; at one month, 66.67% maintained response and 50% maintained remission. The short-acting, noninvasive vaporized route may improve accessibility to psychedelic treatments.
Study at a glance
| 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 |
| Citations | 16 |
| Registration | NCT06094907 |
| Key finding | 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.