Inhaled DMT for Adults With Major Depressive Disorder
Tests inhaled DMT against a low dose in adults with major depression.
Plain-language title generated from the registry record
Registry title: Inhaled DMT for Major Depressive Disorder
Key facts
- Where
- Fortaleza, Natal, Rio de Janeiro, Salvador, and São Paulo, BrazilSee the 5 sites
- Phase
- Phase 2
Where in Brazil
- Hospital de Saúde Mental Professor Frota PintoFortaleza, BrazilNot yet recruiting
- Hospital Universitário Onofre Lopes - HUOL - UFRNNatal, BrazilTaking people
- Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB-UFRJ)Rio de Janeiro, BrazilNot yet recruiting
- Complexo Hospitalar Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)Salvador, BrazilNot yet recruiting
- Instituto de Psiquiatria - Hospital das Clínicas - IPq - HC - USPSão Paulo, BrazilNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universidade Federal do Rio Grande do Norte
- Trial code
- NCT07562191
- Record updated
- 13 July 2026
- Original description
This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD).Read full original descriptionShow less
Randomized, Double-Blind, Placebo-Controlled Phase IIb Trial of Inhaled N,N-Dimethyltryptamine (DMT) for Major Depressive Disorder
This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD).
The study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 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 of inhaled DMT.
Participants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.
Inclusion: 18 years or older, capable of making decisions, and able to provide informed consent; Major Depressive Disorder (MDD) according to DSM-5 criteria; Current depressive episode of moderate to severe intensity; Episode duration of at least two weeks; Baseline MADRS score ≥ 20; No treatment changes (including antidepressants) in the 4 weeks prior to the study; Abstain from psychedelics ≥14 days before dosing (D0).
Exclusion: Current use of MAO inhibitors, unless discontinued at least 14 days prior to dosing; Major cardiac, hepatic, or renal disease; unstable cardiovascular conditions; Severe obesity, uncontrolled diabetes, coagulopathy, thyroid disease, or glaucoma; Neurological risk (e.g., aneurysm, ↑ICP, epilepsy/seizures, severe disorders); MAO deficiency or history of serotonin syndrome; Cluster B personality disorders (incl. borderline with ≥2 suicidal behaviors in past 12 months) or poor therapeutic rapport; Psychotic disorders, MDD with psychotic features, or first-degree family history of psychosis/bipolar disorder; OCD, dissociative disorders, active PTSD, or decompensated eating disorders; Moderate-severe use disorder (past 6 months; except nicotine/caffeine); Lifetime ketamine, PCP, psychedelics, or MDMA use disorder; Cognitive impairment affecting valid assessment; Uncontrolled hypertension, QTc prolongation, arrhythmias, or valvular disease COPD or asthma; Pregnant, breastfeeding, positive test, or no effective contraception; Secondary depression; Mania/hypomania; Psychedelic trial participation in past 12 months.