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CompletedPhase 2

Safety, Tolerability and Antidepressant Effects of DMT in Patients With Depression

NCT06094907 · Universidade Federal do Rio Grande do Norte

Closed to entry
Status
Not accepting participants
Phase 2
Phase
14
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in MADRS scores

    Measured over 7 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 60 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Patients in current treatment for depression with a partial response. Exclusion Criteria: * 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 * 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

Where

1 study site

FacilityCityRegionCountry
Hospital Universitário Onofre LopesNatalRio Grande do NorteBrazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06094907 on ClinicalTrials.gov →

Last updated in the registry 2024-05-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits