NCT07562191RecruitingPhase 2
Inhaled DMT for Major Depressive Disorder
Randomized, Double-Blind, Placebo-Controlled Phase IIb Trial of Inhaled N,N-Dimethyltryptamine (DMT) for Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 27 Mar 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Diseases
- Depression
- NCT number
- NCT07562191
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 140
- From 1 Aug 2026 to the primary completion date, 1 Feb 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of MAO inhibitors, unless discontinued at least 14 days prior to dosing
Other illness
- 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
Lab values
- Uncontrolled hypertension, QTc prolongation, arrhythmias, or valvular disease COPD or asthma
Other
- Pregnant, breastfeeding, positive test, or no effective contraception
- Secondary depression
- Mania/hypomania
- Psychedelic trial participation in past 12 months
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Saúde Mental Professor Frota Pinto Coordinator of this site? Confirm its status | Fortaleza | Brazil | Not yet recruiting |
| Hospital Universitário Onofre Lopes - HUOL - UFRN Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB-UFRJ) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Not yet recruiting |
| Complexo Hospitalar Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA) Coordinator of this site? Confirm its status | Salvador | Brazil | Not yet recruiting |
| Instituto de Psiquiatria - Hospital das Clínicas - IPq - HC - USP Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.