Condition: MDD · Major Depressive Disorder (MDD) · Major Depression · Sponsor: Universidade Federal do Rio Grande do Norte
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Hospital de Saúde Mental Professor Frota Pinto | Fortaleza, Ceará, Brazil | Not Yet Recruiting |
| Complexo Hospitalar Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA) | Salvador, Estado de Bahia, Brazil | Not Yet Recruiting |
| Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB-UFRJ) | Rio de Janeiro, Rio de Janeiro, Brazil | Not Yet Recruiting |
| Hospital Universitário Onofre Lopes - HUOL - UFRN | Natal, Rio Grande do Norte, Brazil | Recruiting |
| Instituto de Psiquiatria - Hospital das Clínicas - IPq - HC - USP | São Paulo, São Paulo, Brazil | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07562191