NCT06094907

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

October 10, 2023

Last Update Submit

May 6, 2024

Conditions

Depressive DisorderDepression, Unipolar

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Secondary Outcomes (5)

  • Change in PHQ-9 scores

    7 days

  • Change in BSI scores.

    1 day

  • Change in MADRS scores 14 days

    14 days

  • Change in MADRS scores 1 month

    1 month

  • Change in MADRS scores 3 months

    3 months

Other Outcomes (18)

  • Systolic Blood Pressure

    up to 2 hours

  • Diastolic Blood Pressure

    up to 2 hours

  • Heart rate

    up to 2 hours

  • +15 more other outcomes

Study Arms (1)

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.

Drug: N,N-Dimethyltryptamine

Interventions

N,N-DimethyltryptamineDRUG

DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg.

Also known as: DMT
N,N-Dimethyltryptamine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in current treatment for depression with a partial response.

You may not qualify if:

  • heart failure
  • liver failure
  • kidney failure
  • uncontrolled high blood pressure
  • history of heart rhythm disorders
  • history of valvular heart disease
  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, 59012300, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 40337754DERIVED

  • Falchi-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.

    PMID: 40258990DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

N,N-Dimethyltryptamine

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesBiogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Draulio Araujo, Ph.D

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

  • Marcelo Falchi, M.D.

    Universidade Federal do Rio Grande do Norte

    STUDY DIRECTOR

  • Fernanda Palhano-Fontes, Ph.D

    Universidade Federal do Rio Grande do Norte

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 23, 2023

Study Start

October 9, 2023

Primary Completion

January 15, 2024

Study Completion

March 30, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)