Inhaled DMT for Major Depressive Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Federal do Rio Grande do Norte
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- N,N-Dimethyltryptamine (15 mg + 60 mg)
- N,N-Dimethyltryptamine (1 mg + 4 mg)
Treatment groups
140 Participants
are divided into 4 treatment groupsSponsors and collaborators
Universidade Federal do Rio Grande do Norte
Lead sponsor
Financiadora de Estudos e Projetos
Collaborator
Source ClinicalTrials.gov