NCT07562191 Inhaled DMT for Major Depressive Disorder
| NCT ID | NCT07562191 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Universidade Federal do Rio Grande do Norte |
| Condition | MDD |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2026-08-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT07562191 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MDD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07562191 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07562191 currently recruiting?
Yes, NCT07562191 is actively recruiting participants. Visit ClinicalTrials.gov or contact Universidade Federal do Rio Grande do Norte to inquire about joining.
Where is the NCT07562191 trial being conducted?
This trial is being conducted at Fortaleza, Brazil, Salvador, Brazil, Rio de Janeiro, Brazil, Natal, Brazil and 1 additional location.
Who is sponsoring the NCT07562191 clinical trial?
NCT07562191 is sponsored by Universidade Federal do Rio Grande do Norte. The trial plans to enroll 140 participants.