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Inhaled DMT for Major Depressive Disorder

RecruitingPhase 2

Sponsor: Universidade Federal do Rio Grande do Norte

Conditions: MDD, Major Depressive Disorder (MDD), Major Depression, Suicidal Ideation, Suicide

Interventions: N,N-Dimethyltryptamine (15 mg + 60 mg), N,N-Dimethyltryptamine (1 mg + 4 mg)

Countries: Brazil

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 criteria:

* Major cardiac, hepatic, or renal disease; unstable cardiovascular conditions
* Uncontrolled hypertension, QTc prolongation, arrhythmias, or valvular disease COPD or asthma
* 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
* Pregnant, breastfeeding, positive test, or no effective contraception
* Secondary depression
* 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
* Mania/hypomania
* 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
* Current use of MAO inhibitors, unless discontinued at least 14 days prior to dosing
* Psychedelic trial participation in past 12 months
* Cognitive impairment affecting valid assessment

Locations (5)

Fortaleza, Ceará, Brazil
Salvador, Estado de Bahia, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Natal, Rio Grande do Norte, Brazil
São Paulo, São Paulo, Brazil