MDDPhase 2DMT-MDDNCT07562191
Inhaled DMT for Major Depressive Disorder
A Phase 2 study testing N,N-Dimethyltryptamine (15 mg + 60 mg) and N,N-Dimethyltryptamine (1 mg + 4 mg) in people with MDD and Major Depressive Disorder (MDD), run by Universidade Federal do Rio Grande do Norte at 5 sites in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MDD, Major Depressive Disorder (MDD), Major Depression
- What is being tested?
- N,N-Dimethyltryptamine (15 mg + 60 mg) and N,N-Dimethyltryptamine (1 mg + 4 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesBrazil
- Study dates
- 1 Aug 2026to 1 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Brazil5 sites, 5 recruiting
- Not yet recruiting
Hospital de Saúde Mental Professor Frota Pinto
Fortaleza, Ceará
Jarbas de Sá Roriz-Filho, MD, +55 85 98206-0526, jarbasroriz@gmail.com
Jarbas de Sá Roriz-Filho, PhD
- Recruiting
Hospital Universitário Onofre Lopes - HUOL - UFRN
Natal, Rio Grande do Norte
Fernanda Palhano-Fontes, PhD, +5584999435830, fernandapalhano@neuro.ufrn.br
Dráulio Barros de Araújo, PhD, +5584991225987, draulio@neuro.ufrn.br
- Not yet recruiting
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB-UFRJ)
Rio de Janeiro, Rio de Janeiro
Tiago Arruda Sanches, PhD, +55 21 98173-7000, tiago@medicina.ufrj.br
Thiago Arruda Sanches, PhD
- Not yet recruiting
Complexo Hospitalar Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)
Salvador, Estado de Bahia
Lucas Quarantini, PhD, +5571992767743, quarantini@gmail.com
Lucas Quarantini, PhD
- Not yet recruiting
Instituto de Psiquiatria - Hospital das Clínicas - IPq - HC - USP
São Paulo, São Paulo
Henrique Ribeiro, MD, +55 11 99712-3513, clinicahenriqueribeiro@gmail.com
Rodrigo Furlan Damiano, PhD
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Phase IIb Trial of Inhaled N,N-Dimethyltryptamine (DMT) for Major Depressive Disorder
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.
Read the detailed description
Major depressive disorder (MDD) is a common and disabling condition associated with high functional burden, incomplete response to standard antidepressant treatments, and persistent suicide risk. Current pharmacological treatments often require weeks to months to achieve meaningful benefit and are limited by delayed onset, side effects, and non-response in a substantial proportion of patients. Other interventions, including esketamine and electroconvulsive therapy, may provide benefit in selected cases but present limitations related to durability, logistics, invasiveness, or tolerability.
N,N-dimethyltryptamine (DMT) is a classic serotonergic psychedelic with rapid onset and short duration of action when administered by inhalation, with acute effects typically lasting about 10 to 20 minutes. Prior studies conducted by the study group suggested that inhaled DMT has a favorable safety and tolerability profile and may produce rapid antidepressant and antisuicidal effects.
This study is a multicenter Phase 2b clinical trial designed in 2 stages. In Stage 1, participants are randomized 1:1 in a double-blind parallel-group design to receive either a higher-dose inhaled DMT regimen (15 mg followed 1 hour later by 60 mg) or a lower-dose inhaled DMT regimen used as an active comparator (1 mg followed 1 hour later by 4 mg). The total planned sample size is 140 randomized participants.
Participants who do not achieve remission at Day 7, defined in the protocol as MADRS >10, enter Stage 2, an open-label extension in which all non-remitters receive the higher-dose DMT regimen on Day 14 (±3 days). The study will also explore the clinical effects of re-dosing among non-remitters from both initial treatment groups.
The trial recruits adults with DSM-5 MDD and a current moderate-to-severe depressive episode, with baseline MADRS score ≥20, stable treatment regimen for at least 4 weeks, and ability to provide informed consent. Participants are followed for up to 12 months after treatment. Recruitment is multicenter and includes psychiatric clinical sites at Brazilian universities.
The primary efficacy objective is to compare the two treatment groups with respect to change in total MADRS score from baseline to Day 7. Secondary outcomes include additional depression, suicidality, safety, functioning, quality-of-life, subjective experience, and psychological measures assessed across follow-up visits through Month 12.
The primary analysis follows the intention-to-treat principle. The primary endpoint is analyzed using a generalized linear mixed model / mixed model for repeated measures framework with fixed effects for treatment group, time, and treatment-by-time interaction, with participant-level random intercepts. Missing data are handled by restricted maximum likelihood estimation. Additional analyses include response and remission comparisons, effect size estimation, and exploratory associations between acute subjective effects, biomarkers, and clinical outcomes.
- Being tested
- N,N-Dimethyltryptamine (15 mg + 60 mg), N,N-Dimethyltryptamine (1 mg + 4 mg)
- Keywords
- DMT, major depressive disorder, N,N-dimethyltryptamine, psychedelic therapy, inhaled DMT, vaporized DMT, suicidality, non invasive
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N,N-Dimethyltryptamine (15 mg + 60 mg)Drug
Also called N,N-dimethyltryptamine, DMT
Inhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a high-dose regimen (15 mg + 60 mg).
N,N-Dimethyltryptamine (1 mg + 4 mg)Drug
Also called N,N-Dimethyltryptamine, DMT
Inhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a low-dose regimen (1 mg + 4 mg).
| Study group | Role | What they receive |
|---|---|---|
| High-Dose DMT → Remitters (No Re-dosing) | Experimental | Participants randomized to the high-dose DMT group (15 mg followed by 60 mg on Day 0) who achieve remission at Day 7 (MADRS ≤10) receive no further dosing and enter long-term follow-up. Receives: Drug: N,N-Dimethyltryptamine (15 mg + 60 mg) |
| High-Dose DMT → Non-Remitters (Open-Label Re-dosing) | Experimental | Participants randomized to the high-dose DMT group (15 mg followed by 60 mg on Day 0) who do not achieve remission at Day 7 (MADRS >10) receive an additional open-label high-dose session (15 mg followed by 60 mg) on Day 14 (±3 days), followed by long-term follow-up. Receives: Drug: N,N-Dimethyltryptamine (15 mg + 60 mg) |
| Low-Dose DMT → Remitters (No Re-dosing) | Active comparator | Participants randomized to the low-dose DMT group (1 mg followed by 4 mg on Day 0) who achieve remission at Day 7 (MADRS ≤10) receive no further dosing and enter long-term follow-up. Receives: Drug: N,N-Dimethyltryptamine (1 mg + 4 mg) |
| Low-Dose DMT → Non-Remitters (Open-Label Re-dosing) | Active comparator | Participants randomized to the low-dose DMT group (1 mg followed by 4 mg on Day 0) who do not achieve remission at Day 7 (MADRS >10) receive an open-label high-dose session (15 mg followed by 60 mg) on Day 14 (±3 days), followed by long-term follow-up. Receives: Drug: N,N-Dimethyltryptamine (15 mg + 60 mg); Drug: N,N-Dimethyltryptamine (1 mg + 4 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Antidepressant efficacy)
The MADRS is a clinician-rated scale used to evaluate the severity of depressive symptoms. It consists of 10 items, each rated from 0 to 6. The total score ranges from 0 to 60. Higher scores indicate greater severity of depression (worse outcome).
Measured: Baseline and Day 7 (D7) after the dosing session
Secondary outcomes (32)
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a clinician-rated scale to monitor depression severity. Total score ranges from 0 to 60. Higher scores indicate greater severity of depression (worse outcome). This measure will assess the durability of the antidepressant effect in participants who achieved remission.
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Number and proportion of adverse events (AEs)
AEs defined by CTCAE v5.0, occurring after DMT administration and compared between study arms across assessment time points.
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Incidence of Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a standardized tool used to evaluate the occurrence, severity, and intensity of suicidal ideation and behavior. It assesses 5 levels of ideation (from "wish to be dead" to "active ideation with specific plan and intent") and 5 types of suicidal behavior. Results are reported as the number of participants who endorse any suicidal ideation or behavior (Yes/No) during the assessment period.
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale - Suicidal Ideation (MADRS-SI, Item 10) Score (Antisuicidal efficacy)
This is a single item (Item 10) from the MADRS scale that specifically evaluates suicidal ideation. The score ranges from 0 to 6. Higher scores indicate greater severity of suicidal thoughts (worse outcome).
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Beck Scale for Suicide Ideation (BSI) Total Score
The Beck Scale for Suicide Ideation (BSI) is a 21-item instrument used to assess the severity of suicidal ideation. Each item is rated on a 3-point scale (0 to 2), yielding a total score ranging from 0 to 42. Higher scores indicate greater severity of suicidal ideation. Higher scores indicate a higher risk of suicide (worse outcome).
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Clinical Global Impression - Severity of Suicidality (CGI-SS) Score
The CGI-SS is a clinician-rated scale used to assess the patient's overall severity of suicidality. The scoring is strictly informed by the findings of the Columbia-Suicide Severity Rating Scale (C-SSRS) to ensure objective evaluation. The score ranges from 1 (normal, not at all suicidal) to 7 (among the most extremely suicidal patients). Higher scores indicate greater severity of suicidality (worse outcome).
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a 40-item self-report questionnaire that differentiates between temporary, situational anxiety (State) and long-term personality anxiety (Trait). It features two 20-item subscales rated on 4-point Likert scales, with higher scores indicating greater anxiety.
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a self-report tool for screening and monitoring depression. Scores range from 0 to 27. Higher scores indicate more severe depressive symptoms (worse outcome).
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Brief Psychiatric Rating Scale (BPRS)
A clinician-rated scale used to assess a range of psychiatric symptoms. In the 18-item version with 1-7 item scoring, total scores range from 18 to 126, with higher scores indicating greater severity of psychopathology.
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Young Mania Rating Scale (YMRS)
The YMRS is a clinician-rated scale to assess manic symptoms. Total scores range from 0 to 60. Higher scores indicate greater severity of mania (worse outcome).
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the World Health Organization Quality of Life - Abbreviated Version (WHOQOL-BREF).
The WHOQOL-BREF is a 26-item instrument that assesses quality of life across four domains: Physical health, Psychological, Social relationships, and Environment. Domain scores can be transformed to a 0-100 scale, with higher scores indicating better quality of life.
Measured: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the EuroQol 5-Dimension 3-Level (EQ-5D-3L) Questionnaire
The EuroQol 5-Dimension 3-Level (EQ-5D-3L) is a standardized instrument used to measure health outcomes. It comprises a descriptive system covering five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS). The VAS records the respondent's self-rated health on a vertical scale ranging from 0 ('Worst imaginable health state') to 100 ('Best imaginable health state'). Higher scores indicate a better health state.
Measured: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Psychedelic Integration Scales (PIS)
The Psychedelic Integration Scales (PIS) is a 24-item self-report instrument designed to assess internal and experiential aspects of how an individual integrates insights from a psychedelic experience into their daily life. Each item is scored on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Total scores are calculated by summing the items and range from 24 to 120, where higher scores indicate a greater internal sense of psychedelic integration (better outcome).
Measured: Baseline to 1 month, 3 months, and 12 months post-intervention
Five-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) Scores
The Five-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) is a 94-item visual analogue scale (VAS) used to retrospectively assess subjective effects of psychoactive substances. It captures five core dimensions: Oceanic Boundlessness, Dread of Ego Dissolution, Visionary Restructuralization, Auditory Alterations, and Vigilance Reduction. Each item is rated from 0 to 100, with higher scores indicating greater alterations from normal waking consciousness. Scores are typically aggregated into dimension-specific and total scores.
Measured: Day of dosing (Day 0), assessed approximately 120 minutes post-administration
Change from Baseline in Brain-Derived Neurotrophic Factor (BDNF) Serum Levels
Change from baseline in serum brain-derived neurotrophic factor (BDNF) levels, measured in nanograms per milliliter (ng/mL). Positive values indicate an increase in serum BDNF levels from baseline, with greater increases representing a more favorable outcome.
Measured: Baseline (pre-dose) and 1 day after the DMT session
Subjective Intensity of the Psychedelic Experience via Visual Analogue Scale (VAS)
A participant-rated Visual Analogue Scale (VAS) used to measure the overall peak intensity of the subjective effects during the DMT session. The scale consists of a 100mm line where 0 represents "No effects at all" and 100 represents "Extremely intense effects." Higher scores indicate a more intense psychedelic experience. Unit of Measure: units on a scale (0-100).
Measured: Day of dosing (Day 0), assessed approximately 120 minutes post-administration
Affective Valence of the Psychedelic Experience via Visual Analogue Scale (VAS).
A participant-rated Visual Analogue Scale (VAS) used to measure the emotional quality (valence) of the experience. The scale is bipolar, ranging from -50 to +50, where -50 represents an "Extremely unpleasant/negative experience," 0 represents a "Neutral experience," and +50 represents an "Extremely pleasant/positive experience." Positive scores indicate a better outcome (pleasant experience), while negative scores indicate a worse outcome (unpleasant experience). Unit of Measure: units on a scale (-50 to +50).
Measured: Day of dosing (Day 0), assessed approximately 120 minutes post-administration
Change from Baseline in Heart Rate during acute DMT effects
Continuous monitoring of heart rate to assess the sympathomimetic effects of DMT. Data will be reported as the change from pre-dose levels. Unit of Measure: Beats per minute (bpm).
Measured: Baseline (pre-dose) up to 90 minutes post-administration
Change from Baseline in Systolic Blood Pressure during acute DMT effects.
Measurement of systolic blood pressure to monitor cardiovascular safety and potential transient hypertension during the experience. Unit of Measure: Millimeters of mercury (mmHg).
Measured: Time Frame: Baseline (pre-dose) up to 90 minutes post-administration.
Change from Baseline in Diastolic Blood Pressure during acute DMT effects.
Measurement of diastolic blood pressure to assess acute cardiovascular response. Unit of Measure: Millimeters of mercury (mmHg).
Measured: Baseline (pre-dose) up to 90 minutes post-administration.
Change from Baseline in Oxygen Saturation (SpO₂) during acute DMT effects.
Monitoring of blood oxygen levels via pulse oximetry to ensure respiratory safety during DMT administration. Unit of Measure: Percentage of oxygen saturation (%).
Measured: Baseline (pre-dose) up to 90 minutes post-administration.
Change from Baseline in the Clinical Global Impression - Severity (CGI-S) Score
The Clinical Global Impression - Severity (CGI-S) is a clinician-rated scale used to assess the patient's overall severity of illness at the time of evaluation. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in The Clinical Global Impression-Improvement (CGI-I) Score
The Clinical Global Impression-Improvement (CGI-I) is a clinician-rated scale that assesses the patient's overall clinical improvement relative to baseline. Scores range from 1 (very much improved) to 7 (very much worse), with lower scores indicating greater clinical improvement.
Time Frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention.
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Death Attitude Profile-Revised (DAP-R) score
The Death Attitude Profile-Revised (DAP-R) is a 32-item multidimensional scale that assesses attitudes toward death across five domains: Fear of Death, Death Avoidance, Neutral Acceptance, Approach Acceptance, and Escape Acceptance. Items are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Higher scores indicate greater endorsement of each respective attitude dimension.
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Duke University Religion Index (DUREL)
The Duke University Religion Index (DUREL) is a 5-item self-report instrument that assesses religious involvement across three dimensions: organizational religious activity (ORA), non-organizational religious activity (NORA), and intrinsic religiosity (IR). Higher scores indicate greater religious or spiritual involvement.
Measured: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Meaning in Life Questionnaire (MLQ)
The Meaning in Life Questionnaire (MLQ) is a 10-item self-report instrument that assesses two distinct dimensions of meaning in life: Presence of Meaning (MLQ-P) and Search for Meaning (MLQ-S). Each item is rated on a 7-point Likert scale ranging from 1 (Absolutely Untrue) to 7 (Absolutely True). Subscale scores range from 5 to 35.
Measured: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Big Five Inventory (BFI) domain scores
The Big Five Inventory (BFI) is a 44-item self-report inventory that assesses the Five Factor Model of personality: Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness to Experience. Each item is rated on a 5-point Likert scale. Domain scores are calculated for each trait and analyzed separately. This measure is used to evaluate potential changes in personality traits following the DMT experience. Changes such as reductions in Neuroticism or increases in Openness are commonly reported in psychedelic research and may be associated with positive psychological outcomes.
Measured: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Cognitive Triad Inventory (CTI) score
The Cognitive Triad Inventory (CTI) is a self-report instrument designed to assess the cognitive triad, encompassing views of the self, world, and future. It evaluates patterns of depressive and non-depressive thinking. Items are rated on a Likert scale, and total scores are calculated, with higher scores indicating more positive and adaptive cognitive patterns (better outcome).
Measured: Baseline to 1 day, 7 days, and 12 months post-intervention
Change from Post-Session in the Psychological Flexibility Scale (Psy-Flex) total score
The Psychological Flexibility Scale (Psy-Flex) is a 6-item self-report instrument designed to assess psychological flexibility based on the Acceptance and Commitment Therapy (ACT) hexaflex model. Each item is rated on a 5-point Likert scale ranging from 1 ("very rarely") to 5 ("very often"). Total scores range from 6 to 30, with higher scores indicating greater psychological flexibility (better outcome).
Measured: Baseline to 7 days, and 12 months post-intervention
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) (12-item version) total score
The WHODAS 2.0 (12-item) is a self-report instrument assessing functioning across six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is rated on a 5-point scale (1 = none to 5 = extreme/cannot do). Total scores are calculated by summing item responses (range 12-60), with higher scores indicating greater disability (worse outcome).
Measured: 1 month, 3 months, and 12 months post-intervention.
Change from Baseline in the Positive and Negative Affect Schedule (PANAS) - Negative Affect (NA) score
The PANAS-NA is a 10-item subscale that assesses subjective distress and unpleasurable engagement, including states such as anger, contempt, and fear. Participants rate each item (e.g., "distressed," "guilty," "scared") on a 5-point Likert scale (1 = "very slightly or not at all" to 5 = "extremely"). The total subscale score ranges from 10 to 50. Higher scores indicate greater negative affect (worse outcome).
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Positive and Negative Affect Schedule (PANAS) - Positive Affect (PA) score
The PANAS-PA is a 10-item subscale that assesses the extent to which a person feels enthusiastic, active, and alert. Participants rate each item (e.g., "interested," "excited," "proud") on a 5-point Likert scale (1 = "very slightly or not at all" to 5 = "extremely"). The total subscale score ranges from 10 to 50. Higher scores indicate a greater level of positive affect (better outcome).
Measured: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter Phase 2, randomized, quadruple-blind, parallel-group clinical trial with an open-label extension. In Stage 1, participants are randomized 1:1 to 1 of 2 treatment arms: a high-dose inhaled DMT regimen (15 mg followed 1 hour later by 60 mg) or a low-dose inhaled DMT regimen used as an active comparator (1 mg followed 1 hour later by 4 mg). Participants who achieve remission at Day 7 (MADRS ≤10) continue follow-up only. Participants who do not achieve remission at Day 7 (MADRS \>10), regardless of initial assignment, enter Stage 2, an open-label extension in which they receive the high-dose DMT regimen on Day 14 (±3 days), followed by continued follow-up.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Responsible party
- Principal investigator, Draulio Barros de Araujo, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562191
- Sponsor's protocol ID
- UFRN-DMT-MDD-IIb-2026
- Other IDs
- FINEP-0366/24
- Acronym
- DMT-MDD
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in this study will be shared. This includes demographic characteristics, baseline clinical data, treatment allocation, dosing information, outcome measures (e.g., MADRS total score and suicidal ideation item, C-SSRS, BSI), safety data (e.g., adverse events and vital signs), and follow-up assessments across study time points. Data will be coded to protect participant identity and will not include any direct identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Phase IIb Trial of Inhaled N,N-Dimethyltryptamine (DMT) for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07562191
- Acronym / sponsor ID
- DMT-MDD / UFRN-DMT-MDD-IIb-2026
- Keywords
- DMT, major depressive disorder, N,N-dimethyltryptamine, psychedelic therapy, inhaled DMT, vaporized DMT, suicidality, non invasive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Major depressive disorder (MDD) is a common and disabling condition associated with high functional burden, incomplete response to standard antidepressant treatments, and persistent suicide risk. Current pharmacological treatments often require weeks to months to achieve meaningful benefit and are limited by delayed onset, side effects, and non-response in a substantial proportion of patients. Other interventions, including esketamine and electroconvulsive therapy, may provide benefit in selected cases but present limitations related to durability, logistics, invasiveness, or tolerability.
N,N-dimethyltryptamine (DMT) is a classic serotonergic psychedelic with rapid onset and short duration of action when administered by inhalation, with acute effects typically lasting about 10 to 20 minutes. Prior studies conducted by the study group suggested that inhaled DMT has a favorable safety and tolerability profile and may produce rapid antidepressant and antisuicidal effects.
This study is a multicenter Phase 2b clinical trial designed in 2 stages. In Stage 1, participants are randomized 1:1 in a double-blind parallel-group design to receive either a higher-dose inhaled DMT regimen (15 mg followed 1 hour later by 60 mg) or a lower-dose inhaled DMT regimen used as an active comparator (1 mg followed 1 hour later by 4 mg). The total planned sample size is 140 randomized participants.
Participants who do not achieve remission at Day 7, defined in the protocol as MADRS >10, enter Stage 2, an open-label extension in which all non-remitters receive the higher-dose DMT regimen on Day 14 (±3 days). The study will also explore the clinical effects of re-dosing among non-remitters from both initial treatment groups.
The trial recruits adults with DSM-5 MDD and a current moderate-to-severe depressive episode, with baseline MADRS score ≥20, stable treatment regimen for at least 4 weeks, and ability to provide informed consent. Participants are followed for up to 12 months after treatment. Recruitment is multicenter and includes psychiatric clinical sites at Brazilian universities.
The primary efficacy objective is to compare the two treatment groups with respect to change in total MADRS score from baseline to Day 7. Secondary outcomes include additional depression, suicidality, safety, functioning, quality-of-life, subjective experience, and psychological measures assessed across follow-up visits through Month 12.
The primary analysis follows the intention-to-treat principle. The primary endpoint is analyzed using a generalized linear mixed model / mixed model for repeated measures framework with fixed effects for treatment group, time, and treatment-by-time interaction, with participant-level random intercepts. Missing data are handled by restricted maximum likelihood estimation. Additional analyses include response and remission comparisons, effect size estimation, and exploratory associations between acute subjective effects, biomarkers, and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a multicenter Phase 2, randomized, quadruple-blind, parallel-group clinical trial with an open-label extension. In Stage 1, participants are randomized 1:1 to 1 of 2 treatment arms: a high-dose inhaled DMT regimen (15 mg followed 1 hour later by 60 mg) or a low-dose inhaled DMT regimen used as an active comparator (1 mg followed 1 hour later by 4 mg). Participants who achieve remission at Day 7 (MADRS ≤10) continue follow-up only. Participants who do not achieve remission at Day 7 (MADRS >10), regardless of initial assignment, enter Stage 2, an open-label extension in which they receive the high-dose DMT regimen on Day 14 (±3 days), followed by continued follow-up.
| Arm | Type | Receives |
|---|---|---|
| High-Dose DMT → Remitters (No Re-dosing) | Experimental | Drug: N,N-Dimethyltryptamine (15 mg + 60 mg)Participants randomized to the high-dose DMT group (15 mg followed by 60 mg on Day 0) who achieve remission at Day 7 (MADRS ≤10) receive no further dosing and enter long-term follow-up. |
| High-Dose DMT → Non-Remitters (Open-Label Re-dosing) | Experimental | Drug: N,N-Dimethyltryptamine (15 mg + 60 mg)Participants randomized to the high-dose DMT group (15 mg followed by 60 mg on Day 0) who do not achieve remission at Day 7 (MADRS >10) receive an additional open-label high-dose session (15 mg followed by 60 mg) on Day 14 (±3 days), followed by long-term follow-up. |
| Low-Dose DMT → Remitters (No Re-dosing) | Active comparator | Drug: N,N-Dimethyltryptamine (1 mg + 4 mg)Participants randomized to the low-dose DMT group (1 mg followed by 4 mg on Day 0) who achieve remission at Day 7 (MADRS ≤10) receive no further dosing and enter long-term follow-up. |
| Low-Dose DMT → Non-Remitters (Open-Label Re-dosing) | Active comparator | Drug: N,N-Dimethyltryptamine (15 mg + 60 mg), Drug: N,N-Dimethyltryptamine (1 mg + 4 mg)Participants randomized to the low-dose DMT group (1 mg followed by 4 mg on Day 0) who do not achieve remission at Day 7 (MADRS >10) receive an open-label high-dose session (15 mg followed by 60 mg) on Day 14 (±3 days), followed by long-term follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N,N-Dimethyltryptamine (15 mg + 60 mg)Also: N,N-dimethyltryptamine, DMTInhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a high-dose regimen (15 mg + 60 mg). | Drug | High-Dose DMT → Non-Remitters (Open-Label Re-dosing), High-Dose DMT → Remitters (No Re-dosing), Low-Dose DMT → Non-Remitters (Open-Label Re-dosing) |
| N,N-Dimethyltryptamine (1 mg + 4 mg)Also: N,N-Dimethyltryptamine, DMTInhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a low-dose regimen (1 mg + 4 mg). | Drug | Low-Dose DMT → Non-Remitters (Open-Label Re-dosing), Low-Dose DMT → Remitters (No Re-dosing) |
Primary outcome
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Antidepressant efficacy)
Time frame: Baseline and Day 7 (D7) after the dosing session
The MADRS is a clinician-rated scale used to evaluate the severity of depressive symptoms. It consists of 10 items, each rated from 0 to 6. The total score ranges from 0 to 60. Higher scores indicate greater severity of depression (worse outcome).
32 secondary outcomes
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Number and proportion of adverse events (AEs)
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Incidence of Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale - Suicidal Ideation (MADRS-SI, Item 10) Score (Antisuicidal efficacy)
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Beck Scale for Suicide Ideation (BSI) Total Score
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Clinical Global Impression - Severity of Suicidality (CGI-SS) Score
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the State-Trait Anxiety Inventory (STAI)
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Young Mania Rating Scale (YMRS)
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the World Health Organization Quality of Life - Abbreviated Version (WHOQOL-BREF).
Time frame: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the EuroQol 5-Dimension 3-Level (EQ-5D-3L) Questionnaire
Time frame: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Psychedelic Integration Scales (PIS)
Time frame: Baseline to 1 month, 3 months, and 12 months post-intervention
Five-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) Scores
Time frame: Day of dosing (Day 0), assessed approximately 120 minutes post-administration
Change from Baseline in Brain-Derived Neurotrophic Factor (BDNF) Serum Levels
Time frame: Baseline (pre-dose) and 1 day after the DMT session
Subjective Intensity of the Psychedelic Experience via Visual Analogue Scale (VAS)
Time frame: Day of dosing (Day 0), assessed approximately 120 minutes post-administration
Affective Valence of the Psychedelic Experience via Visual Analogue Scale (VAS).
Time frame: Day of dosing (Day 0), assessed approximately 120 minutes post-administration
Change from Baseline in Heart Rate during acute DMT effects
Time frame: Baseline (pre-dose) up to 90 minutes post-administration
Change from Baseline in Systolic Blood Pressure during acute DMT effects.
Time frame: Time Frame: Baseline (pre-dose) up to 90 minutes post-administration.
Change from Baseline in Diastolic Blood Pressure during acute DMT effects.
Time frame: Baseline (pre-dose) up to 90 minutes post-administration.
Change from Baseline in Oxygen Saturation (SpO₂) during acute DMT effects.
Time frame: Baseline (pre-dose) up to 90 minutes post-administration.
Change from Baseline in the Clinical Global Impression - Severity (CGI-S) Score
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in The Clinical Global Impression-Improvement (CGI-I) Score
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Death Attitude Profile-Revised (DAP-R) score
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Duke University Religion Index (DUREL)
Time frame: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Meaning in Life Questionnaire (MLQ)
Time frame: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Big Five Inventory (BFI) domain scores
Time frame: Baseline to 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Cognitive Triad Inventory (CTI) score
Time frame: Baseline to 1 day, 7 days, and 12 months post-intervention
Change from Post-Session in the Psychological Flexibility Scale (Psy-Flex) total score
Time frame: Baseline to 7 days, and 12 months post-intervention
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) (12-item version) total score
Time frame: 1 month, 3 months, and 12 months post-intervention.
Change from Baseline in the Positive and Negative Affect Schedule (PANAS) - Negative Affect (NA) score
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Change from Baseline in the Positive and Negative Affect Schedule (PANAS) - Positive Affect (PA) score
Time frame: Baseline (pre-DMT session), 150 minutes post-DMT session (Day 0), Day 1, Day 7, Day 14, 1 month, 3 months, and 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in this study will be shared. This includes demographic characteristics, baseline clinical data, treatment allocation, dosing information, outcome measures (e.g., MADRS total score and suicidal ideation item, C-SSRS, BSI), safety data (e.g., adverse events and vital signs), and follow-up assessments across study time points. Data will be coded to protect participant identity and will not include any direct identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hospital de Saúde Mental Professor Frota Pinto
Fortaleza, Brazil
Complexo Hospitalar Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)
Salvador, Brazil
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB-UFRJ)
Rio de Janeiro, Brazil
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N,N-Dimethyltryptamine (15 mg + 60 mg) and N,N-Dimethyltryptamine (1 mg + 4 mg) in people with MDD and Major Depressive Disorder (MDD), run by Universidade Federal do Rio Grande do Norte at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Antidepressant efficacy) (time frame: Baseline and Day 7 (D7) after the dosing session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.