BridgeMD
New treatment option for MDD
Official title Inhaled DMT for Major Depressive Disorder
ClinicalTrials.gov ID: NCT07562191
What this study is testing
What is N,N-Dimethyltryptamine (15 mg + 60 mg)?
N,N-Dimethyltryptamine (15 mg + 60 mg) is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for mdd.
Also referred to as N,N-dimethyltryptamine, DMT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fortaleza, Ceará, Brazil
- Salvador, Estado de Bahia, Brazil
- Rio de Janeiro, Rio de Janeiro, Brazil
- Natal, Rio Grande do Norte, Brazil
- São Paulo, São Paulo, Brazil
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fortaleza, Ceará, Brazil; Salvador, Estado de Bahia, Brazil; Rio de Janeiro, Rio de Janeiro, Brazil; Natal, Rio Grande do Norte, Brazil; São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.