The antidepressant effects of vaporized N,N-Dimethyltryptamine: a preliminary report in treatment-resistant depression
Marcelo Falchi-Carvalho, Handersson Barros, Raynara Bolcont, Sophie Laborde, Isabel Wießner, Sérgio Ruschi Bergamachi Silva, Daniel Montanini, D. Barbosa, Ewerton Teixeira, Rodrigo Florence-Vilela, Raíssa Nóbrega de Almeida, Rosana K. A. de Macedo, Flávia Arichelle, Érica J. Pantrigo, Emerson Arcoverde, Nicole Leite Galvão‐coelho, Dráulio Barros de Araújo, Fernanda Palhano-Fontes
medRxiv January 4, 2024 preprint DOI: 10.1101/2024.01.03.23300610 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label, fixed-order, dose-escalation study (Phase 2a clinical trial) |
|---|---|
| Sample size | 6 |
| Population | Patients with treatment-resistant depression |
| Intervention | Vaporized DMT |
| Dose | 15 mg then 60 mg |
| Duration | Single-day session, follow-up to one month |
| Topics | Anxiety Depression 5-MeO-DMT DMT |
| Keywords | Antidepressant Depression economics Rating scale Clinical trial |
| Citations | 5 |
| Registration | NCT06094907 |
| Key findings | Vaporized DMT produced rapid and sustained antidepressant effects in treatment-resistant depression, with 83% of patients responding by day seven and 67% maintaining response at one month. |
Abstract
Abstract Introduction N,N-Dimethyltryptamine (DMT), a naturally occurring psychedelic tryptamine contained in the indigenous ayahuasca brew has shown antidepressant effects. This Phase 2a clinical trial investigates for the first time the efficacy of isolated DMT in treatment-resistant depression (TRD).
Methods: 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.
Results: Significant reductions in MADRS and PHQ-9 scores were noted from Day 1 to M1. The mean MADRS score variation from baseline to 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.
Discussion: 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 non-invasive route and short-acting nature of DMT offer practical advantages, potentially enhancing accessibility to psychedelic treatments. Clinical Trial registration Clinicaltrials.gov NCT06094907
Comparable studies
Other non-randomized and open-label trials on DMT for depression, most cited first.