Inhaled DMT for Major Depressive Disorder
Recruiting
Phase 2
Interventional Study
MDD
Major Depressive Disorder (MDD)
Major Depression
Suicidal Ideation
Suicide
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- Universidade Federal do Rio Grande do Norte · Other
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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 recei…
Trial Locations
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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…
Contacts
No contact information available.