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Home/Research/5-MeO-DMT/Depressive Disorders

5-MeO-DMT for Depressive Disorders

35 papers and 7 clinical trials exploring 5-meo-dmt as a treatment for depressive disorders.

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
IndicationApproximately 260 million people worldwide are affected by depression.

Depressive Disorders

Depressive disorders, particularly major depressive disorder (MDD), are significant contributors to global mental health issues. Research into the therapeutic potential of psychedelics, such as psilocybin and ketamine, offers promising avenues for treatment, especially for cases that are resistant to conventional therapies.

Full Depressive Disorders profile

Academic Research

35 papers
Paywallindividual

Inhaled Mebufotenin (GH001) for Adult Patients With Postpartum Depression: A Phase 2a Open-Label Clinical Trial

This Phase IIa open-label proof-of-concept trial (n=10) investigated GH001, an inhaled formulation of 5-MeO-DMT (up to 6, 12, and 18 mg), in women with postpartum depression. All patients responded and achieved remission by day 8, with effects first seen two hours after the final dose. It was well tolerated, with headache the most common mild to moderate side effect.

Published
June 3, 2026
Journal
Journal of Clinical Psychiatry
Authors
Johnson, M., Baldo, P. A., Arbe, E., Brennan, B., Cohen, S. E., Doolin, K., Gann, W., Gregory, D., Keady, S., Kriger, K., MacIsaac, R., Ratcliffe, S., Rubinow, D. R., Svendsen, C. B., Terwey, T. H., Tully, D., Valcheva, V., Zantvoord, J. B., Deligiannidis, K. M.
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.
Open Accessindividual

Intranasal 5-MeO-DMT Concomitant with SSRI for Treatment-Resistant Depression: A Proof-of-Concept Trial

This open-label phase 2a trial (n=12) tested a single intranasal dose of 5-MeO-DMT given alongside stable SSRI treatment in adults with treatment-resistant depression and found it was generally well tolerated, with mostly short-lived nasal and stomach side effects. Depressive symptoms fell quickly and stayed lower over 12 weeks in both dose groups.

Published
March 24, 2026
Journal
CNS Drugs
Authors
Seynaeve, M., Dunbar, F., Hindocha, C., Ermakova, A. O., Pierce, M., Conley, R. R., Roberts, C.
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

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published
February 18, 2026
Journal
JAMA Psychiatry
Authors
Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.
Open Accessindividual

Complex slow waves in the human brain under 5-MeO-DMT

This naturalistic EEG study (n=29) examines the effects of inhaled synthetic 5-MeO-DMT (12mg) on brain activity in healthy individuals. It finds that 5-MeO-DMT radically reorganises low-frequency neural activity flows, making them incoherent, heterogeneous, and nonrecurring. It also causes broadband activity to exhibit slower, more stable, low-dimensional behaviour with increased energy barriers to rapid global shifts.

Published
August 1, 2025
Journal
Cell Reports
Authors
Blackburne, G., Mcalpine, R. G., Fabus, M., Liardi, A., Kamboj, S. K., Mediano, P. A. M., Skipper, J. I.

Clinical Trials

7 trials
CompletedPhase I/II

Efficacy of Sublingual 5-MeO-DMT for Reducing Anxiety and Depression in MCI (5-MeO-DMT)

This Phase I/II randomised, triple-blind, placebo-controlled trial (n=20) will study the effects of sublingual 5-MeO-DMT (6 mg, administered weekly for four weeks) on anxiety, depression, and cognitive function in individuals with mild to moderate Alzheimer's disease.

Started
December 15, 2024
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06812221
CompletedPhase I/II

Safety, Tolerability, and Efficacy of Sublingual Microdoses of 5-MeO-DMT for Depression and Anxiety (5-MeO-DMT)

This Phase I/II randomised, triple-blind, placebo-controlled trial (n=40) will investigate the safety, tolerability, and potential therapeutic effects of sublingual 5-MeO-DMT (6 mg, 9 mg, or 12 mg) in individuals with elevated symptoms of anxiety and depression. Participants will receive one dose per week for four weeks, with monitoring throughout the trial.

Started
October 21, 2024
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06816667
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
TerminatedPhase II

Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

Open-label, single-arm Phase II multicentre study (n=6 actual) evaluating inhaled GH001 individualized dosing regimen (up to three escalating doses 6, 12, 18 mg in one day) in adults with bipolar II disorder experiencing a major depressive episode.

Started
April 6, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT05839509
TerminatedPhase II

Phase 2 Clinical Trial of GH001 in Postpartum Depression

This is a single-arm, open-label Phase II clinical trial (n=10) investigating the anti-depressive effects of GH001 in postpartum depression (PPD) patients.

Started
March 2, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT05804708
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

Explore further

Search all 5-MeO-DMT papers Search all Depressive Disorders trials Full 5-MeO-DMT profile Full Depressive Disorders profile