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Home/Research/DMT/Depressive Disorders

DMT for Depressive Disorders

51 papers and 11 clinical trials exploring dmt as a treatment for depressive disorders.

CompoundTryptamine

DMT

A powerful, short-acting tryptamine psychedelic found in many botanical sources, known for rapid onset and intense subjective experiences.

Full 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

51 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.
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

Inhaled N, N-dimethyltryptamine diminishes connectivity between the ventral tegmental area and the nucleus accumbens: relevance to pathologies of mesolimbic and mesocortical pathways

In a within-subject pharmacoimaging study of 11 healthy psychedelic-experienced volunteers, inhaled DMT acutely reduced connectivity between the left ventral tegmental area and the right nucleus accumbens while increasing connectivity between the nucleus accumbens and anterior cingulate cortex and between the medial prefrontal cortex and anterior cingulate. These connectivity shifts correlated with changes in volition and perception and suggest a potential therapeutic mechanism for disorders of reward processing.

Published
December 12, 2025
Journal
Scientific Reports
Authors
Lima, G., Soares, C., Teixeira, M., Pais, M., Cabral, C., Rijo, P., Castelo-Branco, M.
Open Accessindividual

Naturalistic psychedelic use and changes in depressive symptoms

This longitudinal observational study (n=12,345) of U.S. residents found that naturalistic psychedelic use (n=505, 4.1% of participants) was associated with modest increases in depressive symptoms, particularly when occurring in 'risk contexts' characterised by negative mindset and lack of psychological support, with challenging psychedelic experiences mediating this relationship and suggesting that unsupervised psychedelic use may not be generally therapeutic and could worsen depression under certain circumstances.

Published
December 1, 2025
Journal
Journal of Affective Disorders
Authors
Simonsson, O., Hendricks, P. S., Swords, C. M., Osika, W., Goldberg, S. B.
Open Accessindividual

A novel psychedelic 5-HT2A receptor agonist GM-2505: The pharmacokinetic, safety, and pharmacodynamic profile from a randomized trial healthy volunteer

In a randomized, placebo‑controlled ascending‑dose study in 48 healthy volunteers, single IV doses of GM‑2505 up to 20 mg were well tolerated and showed dose‑proportional pharmacokinetics (t1/2 40–50 min) with dose‑dependent neuroendocrine, neurophysiological and subjective psychedelic effects, including decreased theta/alpha and increased gamma EEG power. The duration of cardiovascular and subjective effects was intermediate between psilocybin and DMT, indicating a practical 10–15 mg IV dose range for supervised clinical use.

Published
October 16, 2025
Journal
Journal of Psychopharmacology
Authors
Marek, G. J., Makai-Bölöni, S., Umbricht, D., Christian, E. P., Winters, J., Dvorak, D., Raines, S., Hughes, Z. A., Austin, E. W., Klein, A. K., Leong, W., Krol, F. J., Van Der Graaf, A. J., Juachon, M. J., Otto, M. E., Borghans, L. G. J. M., Jacobs, G., Kruegel, A. C., Sporn, J.
Paywallindividual

Zalsupindole is a Nondissociative, Nonhallucinogenic Neuroplastogen with Therapeutic Effects Comparable to Ketamine and Psychedelics

This rat study found that zalsupindole (third-generation psychedelic) produced robust effects on structural and functional neuroplasticity in the prefrontal cortex as well as sustained antidepressant-like responses comparable to or greater than those of ketamine, psilocybin, and DMT, despite lacking any of the acute cellular and behavioural characteristics of hallucinogenic or dissociative compounds.

Published
October 13, 2025
Journal
ACS Chemical Neuroscience
Authors
Agrawal, R., Gillie, D., Mungenast, A., Chytil, M., Engel, S., Wu, M. C., Rasmussen, K., Salinas, E., Olson, D. E.

Clinical Trials

11 trials
RecruitingPhase II

Inhaled DMT for Major Depressive Disorder

This Phase IIb, randomised, double-blind, active-controlled trial (n=140) will evaluate the efficacy and safety of inhaled DMT in adults with major depressive disorder (MDD). It will assess whether a higher-dose inhaled DMT regimen can more rapidly reduce depressive symptoms and suicide risk than a lower-dose active comparator, with primary outcomes focused on change in Montgomery-Åsberg Depression Rating Scale (MADRS) score and incidence of suicidal ideation and behaviour. Participants will be allocated 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg, administered via a Volcano Medic 2 vaporiser in two inhalations. Those who do not achieve remission at Day 7 (MADRS >10) will enter an open-label extension and receive a high-dose session on Day 14 (±3 days), while remitters will not be re-dosed; all participants will then be followed for up to 12 months to examine durability of response, safety, functioning and quality of life.

Started
August 1, 2026
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT07562191
RecruitingPhase NA

Antidepressant Response of DMT Masked With Propofol (DMT4D)

This randomised, placebo-controlled, quadruple-masked trial (n=112) will investigate whether the antidepressant effects of DMT (2 mg/min over 20 minutes; total ~40 mg) in patients with MDD depend on the subjective psychedelic experience by comparing DMT vs placebo under propofol sedation or no sedation.

Started
April 1, 2025
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06927076
RecruitingPhase I

Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans (DMT-Bolus)

This Phase I, randomised, placebo-controlled, triple-masked, crossover design trial (n=60) will investigate the safety, tolerability, electrophysiological effects, and efficacy of dimethyltryptamine (DMT) in individuals with major depressive disorder (MDD) and healthy controls.

Started
March 1, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06671977
Active not recruitingPhase II

A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) With Depressive Symptoms

This double-blind, active-controlled study (n=36) aims to evaluate the preliminary clinical efficacy, safety, tolerability, and pharmacokinetics of CYB004 (DMT) in participants diagnosed with Generalized Anxiety Disorder (GAD) with depressive symptoms.

Started
May 1, 2024
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06051721
CompletedPhase II

Safety, Tolerability and Antidepressant Effects of DMT in Patients With Depression

Open-label Phase II single-group study (n=14) assessing ascending inhaled DMT (15 mg then 60 mg on a single day) for patients with partial response in depression.

Started
October 9, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT06094907
CompletedPhase I

IM and IV SPL026 Drug Product in Healthy Participants

Open-label, crossover study (n=14) assessing IM and IV SPL026 (DMT) in healthy participants with varying psychedelic experience (Part A crossover IM→IV; Part B single IM).

Started
January 3, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT05644093

Explore further

Search all DMT papers Search all Depressive Disorders trials Full DMT profile Full Depressive Disorders profile