Skip to content
RecruitingNot applicable

Antidepressant Response of DMT Masked With Propofol

NCT06927076 · DMT4D · University Hospital, Basel, Switzerland

Recruiting
Status
Accepting participants
Not applicable
Phase
112
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The aim of this study is to elucidate if the anti-depressive effect of N,N-dimethyltryptamine (DMT) is based on a biological mechanisms including neuroplasticity and anti-inflammatory effect or due to the subjective psychedelic experience.

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

  • long term changes in depressive symptoms (MADRS)

    Measured over baseline (before intervention) and on day 14 post-intervention

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

21 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Participants must meet DSM-5 criteria for MDD of at least moderate severity (MADRS≥20). 2. Participants either currently do not use antidepressants or are treated with a stable dose for at least 4 weeks prior to randomization. 3. Age ≥ 21 years old. 4. Sufficient understanding of the German language. 5. Able to understand the study procedures and risks and willing to adhere to the protocol and sign the consent form. 6. Willing not to drive or operate heavy machinery on the treatment day. 7. Willing to refrain from more than 7 standard alcoholic drinks a week, more than 10 cigarettes a day, more than 2 cups of coffee a day, and any illicit substances during study participation. 8. Willing to use effective contraceptive measures throughout study participation. Exclusion Criteria: 1. Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features. 2. First-degree relative with a psychotic or bipolar disorder. 3. Significant prodromal psychotic symptoms (Prodromal Questionnaire-16 symptoms ≥ 6). 4. Psychiatric condition judged to be incompatible with establishment of rapport with study team members and/or safe exposure to DMT, e.g. diagnosed or suspected borderline personality disorder. 5. Current post-traumatic stress disorder or acute stress reaction due to a traumatic event. 6. Post-partum depression. 7. Pregnant or breastfeeding women. 8. Current or recent history of significant suicide ideation or suicide behavior within the past 6 months. 9. Current severe substance use disorder other than nicotine. 10. Planned ketamine, other psychedelic, or electroconvulsive treatment or any such treatment within the past 3 months. 11. Any lifetime use of DMT, use of any other psychedelics within last 3 month or lifetime use of any other psychedelics more than 15 times. 12. Patients who are treated with neuroleptics or known antagonists of 5-HT2 receptors or monoamine oxidase inhibitors (MAOI) and are not able/willing to pause. 13. Increased risk for adverse reactions to propofol or soja products. 14. Increased risk for aspiration. 15. Increased risk for difficult mask ventilation.

Where

1 study site

FacilityCityRegionCountry
University Hospital BaselBaselSwitzerland

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.

NCT06927076 on ClinicalTrials.gov →

Last updated in the registry 2026-04-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits