Depressive DisorderPhase 2NCT06094907
Safety, Tolerability and Antidepressant Effects of DMT in Patients With Depression
A Phase 2 study testing N,N-Dimethyltryptamine in people with Depressive Disorder and Depression, Unipolar, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depressive Disorder, Depression, Unipolar
- What is being tested?
- N,N-Dimethyltryptamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Oct 2023to 30 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients in current treatment for depression with a partial response.
Who cannot join
- heart failure
- liver failure
- kidney failure
- uncontrolled high blood pressure
- history of heart rhythm disorders
- history of valvular heart disease
Show all 27Show fewer
- history of chronic obstructive pulmonary disease (COPD)
- active or in treatment for bronchial asthma
- severe obesity
- coagulation disorders
- clinical evidence or history of increased intracranial
- clinical evidence or history of cerebrospinal pressure
- history or reports of epilepsy
- severe neurological disease
- pregnancy
- reported or clinically recognized thyroid disorders
- diagnosis or family suspicion of genetic monoamine deficiency oxidase
- previous adverse response to psychedelic substances
- symptoms or family members with a present or past psychotic disorder
- dissociative identity disorder
- bipolar affective disorder
- prodromal symptoms of schizophrenia
- problematic use or abuse of alcohol or other psychoactive substances (except tobacco)
- acute or subacute risk of suicide
- acute flu symptoms
- symptoms of airway infection
- contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Onofre Lopes
Natal, Rio Grande do Norte, 59012300
About this study
Official title: An Open Label Trial of Inhaled N,N-Dimethyltryptamine in Patients With Partial Response in Depression.
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
Read the detailed description
This is a phase II open-label, single-ascending, fixed-order study to assess the feasibility and efficacy of inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
- Conditions
- Depressive Disorder, Depression, Unipolar
- Being tested
- N,N-Dimethyltryptamine
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N,N-DimethyltryptamineDrug
Also called DMT
DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg.
| Study group | Role | What they receive |
|---|---|---|
| N,N-Dimethyltryptamine | Experimental | Administration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 1-hour dose interval. Receives: Drug: N,N-Dimethyltryptamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS scores
Change in MADRS scores from baseline to 7 days after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression.
Measured: 7 days
Secondary outcomes (5)
Change in PHQ-9 scores
Change in PHQ-9 scores from baseline to 7 days after the dosing session. The Patient Health Questionnaire-9 (PHQ-9) is a questionnaire self-reported assessing the severity of the depression. The scale was in french and has 9 items, with an overall score ranging from 0 to 27 points. Higher score indicates more severe depression.
Measured: 7 days
Change in BSI scores.
Change in BSI scores from baseline to 1 day after the dosing session. The Beck rating scale for suicidal ideation (BSI) is a 21-item self-report questionnaire. Each item is rated on a scale from 0 to 2, resulting in a total score ranging from 0 to 38.
Measured: 1 day
Change in MADRS scores 14 days
Change in MADRS scores from baseline to 14 day after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression.
Measured: 14 days
Change in MADRS scores 1 month
Change in MADRS scores from baseline to one month after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression.
Measured: 1 month
Change in MADRS scores 3 months
Change in MADRS scores from baseline to three months after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start9 Oct 2023
- Primary completion15 Jan 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Draulio Barros de Araujo, Universidade Federal do Rio Grande do Norte
- Investigators
- Draulio Araujo, Ph.D, Principal investigator, Universidade Federal do Rio Grande do NorteMarcelo Falchi, M.D., Study director, Universidade Federal do Rio Grande do NorteFernanda Palhano-Fontes, Ph.D, Study director, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094907
- Sponsor's protocol ID
- DMTPRD
- Status last verified
- May 2024
- First submitted
- 10 Oct 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Falchi-Carvalho M, Barros H, Bolcont R, Laborde S, Wiessner I, Ruschi B Silva S, Montanini D, Barbosa DC, Teixeira E, Florence-Vilela R, Almeida R, de Macedo RKA, Arichelle F, Pantrigo EJ, Costa-Macedo JV, Arcoverde E, Galvao-Coelho N, Araujo DB, Palhano-Fontes F. The Antidepressant Effects of Vaporized N,N-Dimethyltryptamine: An Open-Label Pilot Trial in Treatment-Resistant Depression. Psychedelic Med (New Rochelle). 2025 Feb 27;3(1):48-52. doi: 10.1089/psymed.2024.0002. eCollection 2025 Mar.
PubMed 40337754Falchi-Carvalho M, Palhano-Fontes F, Wiessner I, Barros H, Bolcont R, Laborde S, Ruschi B Silva S, Montanini D, C Barbosa D, Teixeira E, Florence-Vilela R, Almeida R, K A de Macedo R, Arichelle F, J Pantrigo E, V Costa-Macedo J, da Cruz Nunes JA, de Araujo Costa Neto LA, Nunes Ferreira LF, Dantas Correa L, da Costa Bezerra RB, Arcoverde E, Galvao-Coelho N, B Araujo D. Rapid and sustained antidepressant effects of vaporized N,N-dimethyltryptamine: a phase 2a clinical trial in treatment-resistant depression. Neuropsychopharmacology. 2025 May;50(6):895-903. doi: 10.1038/s41386-025-02091-6. Epub 2025 Apr 22.
PubMed 40258990
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial of Inhaled N,N-Dimethyltryptamine in Patients With Partial Response in Depression.
- ClinicalTrials.gov ID
- NCT06094907
- Acronym / sponsor ID
- DMTPRD
- Conditions
- Depressive Disorder, Depression, Unipolar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 23 Oct 2023 (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 study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
Detailed description
This is a phase II open-label, single-ascending, fixed-order study to assess the feasibility and efficacy of inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N,N-Dimethyltryptamine | Experimental | Drug: N,N-DimethyltryptamineAdministration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 1-hour dose interval. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients in current treatment for depression with a partial response.
Key exclusion criteria (27 listed)
- heart failure
- liver failure
- kidney failure
- uncontrolled high blood pressure
- history of heart rhythm disorders
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-DimethyltryptamineAlso: DMTDMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg. | Drug | N,N-Dimethyltryptamine |
Primary outcome
Change in MADRS scores
Time frame: 7 days
Change in MADRS scores from baseline to 7 days after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression.
5 secondary outcomes
Change in PHQ-9 scores
Time frame: 7 days
Change in BSI scores.
Time frame: 1 day
Change in MADRS scores 14 days
Time frame: 14 days
Change in MADRS scores 1 month
Time frame: 1 month
Change in MADRS scores 3 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 40337754Falchi-Carvalho M, Barros H, Bolcont R, Laborde S, Wiessner I, Ruschi B Silva S, Montanini D, Barbosa DC, Teixeira E, Florence-Vilela R, Almeida R, de Macedo RKA, Arichelle F, Pantrigo EJ, Costa-Macedo JV, Arcoverde E, Galvao-Coelho N, Araujo DB, Palhano-Fontes F. The Antidepressant Effects of Vaporized N,N-Dimethyltryptamine: An Open-Label Pilot Trial in Treatment-Resistant Depression. Psychedelic Med (New Rochelle). 2025 Feb 27;3(1):48-52. doi: 10.1089/psymed.2024.0002. eCollection 2025 Mar.
- Derived from this study: PubMed 40258990Falchi-Carvalho M, Palhano-Fontes F, Wiessner I, Barros H, Bolcont R, Laborde S, Ruschi B Silva S, Montanini D, C Barbosa D, Teixeira E, Florence-Vilela R, Almeida R, K A de Macedo R, Arichelle F, J Pantrigo E, V Costa-Macedo J, da Cruz Nunes JA, de Araujo Costa Neto LA, Nunes Ferreira LF, Dantas Correa L, da Costa Bezerra RB, Arcoverde E, Galvao-Coelho N, B Araujo D. Rapid and sustained antidepressant effects of vaporized N,N-dimethyltryptamine: a phase 2a clinical trial in treatment-resistant depression. Neuropsychopharmacology. 2025 May;50(6):895-903. doi: 10.1038/s41386-025-02091-6. Epub 2025 Apr 22.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Draulio Araujo, Ph.D principal investigator
Universidade Federal do Rio Grande do Norte
Marcelo Falchi, M.D. study director
Universidade Federal do Rio Grande do Norte
Fernanda Palhano-Fontes, Ph.D study director
Universidade Federal do Rio Grande do Norte
1 site 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 in people with Depressive Disorder and Depression, Unipolar, run by Universidade Federal do Rio Grande do Norte at 1 site 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 1 inclusion and 27 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: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MADRS scores (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06094907, which also lists 2 linked publications.
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 8 May 2024.