Inhaled DMT for Major Depressive Disorder

NCT07562191 · tracked via the Priya Life Science Brazil tracker

Sponsor

Universidade Federal do Rio Grande do Norte

Phase

Phase 2

Started

2026-08-01

Last updated

2026-07-13

Condition(s) studied

MDDMajor Depressive Disorder (MDD)Major DepressionSuicidal IdeationSuicide

Investigational drug(s) / intervention(s)

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

N,N-Dimethyltryptamine (15 mg + 60 mg): Inhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a high-dose regimen (15 mg + 60 mg).

N,N-Dimethyltryptamine (1 mg + 4 mg): Inhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a low-dose regimen (1 mg + 4 mg).

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Antidepressant efficacy) — Baseline and Day 7 (D7) after the dosing session
The MADRS is a clinician-rated scale used to evaluate the severity of depressive symptoms. It consists of 10 items, each rated from 0 to 6. The total score ranges from 0 to 60. Higher scores indicate greater severity of depression (worse outcome).

Trial sites (5)

Facility	City	Region	Status
Hospital de Saúde Mental Professor Frota Pinto	Fortaleza	Ceará	Not Yet Recruiting
Complexo Hospitalar Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)	Salvador	Estado de Bahia	Not Yet Recruiting
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB-UFRJ)	Rio de Janeiro	Rio de Janeiro	Not Yet Recruiting
Hospital Universitário Onofre Lopes - HUOL - UFRN	Natal	Rio Grande do Norte	Recruiting
Instituto de Psiquiatria - Hospital das Clínicas - IPq - HC - USP	São Paulo	São Paulo	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07562191 on ClinicalTrials.gov ↗ ← All trials in Brazil