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Home/Research/5-MeO-DMT/Treatment-Resistant Depression (TRD)

5-MeO-DMT for Treatment-Resistant Depression (TRD)

6 papers and 3 clinical trials exploring 5-meo-dmt as a treatment for treatment-resistant depression (trd).

CompoundTryptamine

5-MeO-DMT

A potent tryptamine psychedelic known for profound mystical experiences, currently under clinical investigation for TRD and anxiety.

Full 5-MeO-DMT profile
IndicationAffects roughly a third of people with depression

Treatment-Resistant Depression (TRD)

Treatment-resistant depression, depression that has not responded to at least two adequate antidepressant trials, is where psychedelic and rapid-acting therapies are furthest along. Esketamine is FDA-approved, and in 2025 a synthetic psilocybin became the first classic psychedelic to meet a Phase 3 endpoint for depression. The progress is real, but so are the caveats: modest effect sizes, short-lived benefits, and unresolved questions about how well these trials are blinded.

Full Treatment-Resistant Depression (TRD) profile

Academic Research

6 papers
Open Accessindividual

GH001 vs Placebo in Patients With Treatment-Resistant Depression A Randomized Clinical Trial

This randomised, double-blind, placebo-controlled Phase IIb trial (n=81) found that a single-day inhaled synthetic mebufotenin treatment (GH001; 5-MeO-DMT) reduced depression symptoms more than placebo in adults with treatment-resistant depression, with remission in over half of those treated. No severe or serious adverse events were reported during the placebo-controlled period.

Published
March 25, 2026
Journal
JAMA Psychiatry
Authors
Cubała, W. J., Bajbouj, M., Bauer, M., Baune, B. T., Cardoner, N., Devlin, F., Doolin, K., Dueñas Herrero, R. M., Elices, M., Feeney, A., Gałuszko-Węgielnik, M., Jakuszkowiak-Wojten, K., Janů, L., Kelly, J. R., Ledden, K., Maclsaac, R., Madero, S., McInerney, S. J., Montejo, A. L., Nawka, A., Páleníček, T., Pérez Solà, V., Ramaekers, J. G., Reif, A., Ritter, P., Ryan, F., Svendsen, C. B., Sweeney, C., Terwey, T. H., Trivedi, M. H., Valcheva, V., Vieta, E., Thase, M. E.
Paywallindividual

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

This 12‑week, open‑label Phase IIa trial of a single 10 mg intranasal dose of 5‑MeO-DMT (BPL‑003) in patients (n=12) with treatment‑resistant major depressive disorder, found that the drug was generally well tolerated with mostly mild–moderate adverse events and rapid discharge readiness (median ~98 minutes). A rapid and sustained mean MADRS reduction of 12–13 points was observed from Day 2 through Day 85, with most participants meeting response criteria and several achieving remission, supporting further evaluation in larger controlled trials.

Published
February 27, 2026
Journal
Journal of Psychopharmacology
Authors
Roberts, C., Seynaeve, M., Ermakova, A. O., Dunbar, F., Wells, H., Puri, A., Bird, C., Rucker, J. J.
Open Accessindividual

Evaluation of the peak experience scale as a rapid assessment tool for the strength of a psychoactive experience with 5-MeO-DMT

The three-item Peak Experience Scale (PES) reliably and rapidly measures the strength of 5‑MeO‑DMT experiences, showing dose-related increases, a single PCA component explaining 83.5% of variance, high internal consistency (α = 0.896) and strong correlations with established measures (MEQ-30, EDI, 5D-ASC) but not the CEQ. The authors conclude the PES could be used to gain fast insight into psychedelic intensity in individual patients and to guide dose and re-dose decisions for rapid-acting psychedelics.

Published
June 2, 2025
Journal
Frontiers in Psychology
Authors
Reckweg, J. T., Mason, N. L., Theunissen, E. L., Svendsen, C. B., Terwey, T. H., Ramaekers, J. G.
Paywallmeta

5-MeO-DMT: An atypical psychedelic with unique pharmacology, phenomenology & risk?

This review (2023) of 5-MeO-DMT, a tryptamine with unique antidepressant potential, notes its distinct effects compared to typical psychedelics. It draws parallels between 5-MeO-DMT's effects and epileptiform activity, particularly through 5-HT1A receptor interactions, suggesting its therapeutic action may resemble electroconvulsive therapy (ECT).

Published
December 11, 2023
Journal
Psychopharmacology
Authors
Dourron, H. M., Nichols, C. D., Simonsson, O., Bradley, M. K., Carhart-Harris, R. L., Hendricks, P. S.
Open Accessmeta

Effects of psychedelics on neurogenesis: A systematic review of pre-clinical studies

This systematic review of 68 pre-clinical (and related human) studies categorised psychedelics into five classes—CB1 agonists, NMDA antagonists, harmala alkaloids, tryptamines and entactogens—and synthesised their reported effects on adult neurogenesis and related brain plasticity. The authors conclude that diverse psychedelic compounds can modulate the birth of new neurons and neural plasticity, supporting further investigation into their therapeutic potential for neuropsychiatric disorders.

Published
July 20, 2023
Journal
Biorxiv
Authors
Lima da Cruz, R. V., Leão, R. N., Moulin, T. C.
Open Accessindividual

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

In a Phase 1/2 trial of 16 adults with treatment‑resistant depression, inhaled 5‑MeO‑DMT (GH001) was evaluated as single doses (12 mg, 18 mg) and as an individualized regimen of up to three ascending doses in one day. GH001 was well tolerated and produced ultra‑rapid antidepressant effects, with remission at day 7 in 7/8 (87.5%) patients in the individualized dosing group, markedly higher than the single‑dose arms.

Published
June 20, 2023
Journal
Frontiers in Psychiatry
Authors
Reckweg, J., van Leeuwen, C., Theunissen, E. L., Mason, N. L., Paci, R., Terwey, T. H., Ramaekers, J. G.

Clinical Trials

3 trials
CompletedPhase II

A Trial of GH001 in Patients With Treatment-resistant Depression

This randomised, double-blind, placebo-controlled Phase IIb trial (n=81) tested inhaled GH001 (5‑MeO‑DMT) individualised dosing regimen (IDR) vs placebo in patients with treatment‑resistant depression (TRD).

Started
May 24, 2023
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT05800860
RecruitingPhase II

An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression

This open-label Phase IIa trial (n=64) evaluates the safety and tolerability of up to two doses of 5-MeO-DMT (BPL-003) in patients with treatment-resistant depression (TRD), for which some will receive SSRIs at the same time.

Started
February 10, 2023
Type
interventional
Randomized
No
Registry ID
NCT05660642
CompletedPhase I/II

Clinical Study of GH001 in Depression

The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of depressive symptoms, and its dose-related psychoactive effects in patients with Treatment-Resistant Depression (TRD).

Started
November 12, 2019
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT04698603

Explore further

Search all 5-MeO-DMT papers Search all Treatment-Resistant Depression (TRD) trials Full 5-MeO-DMT profile Full Treatment-Resistant Depression (TRD) profile