Antidepressant Response of DMT Masked With Propofol

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder, Psychedelic Experiences

In brief

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.

Key facts

Study ID

NCT06927076

Run by

University Hospital, Basel, Switzerland

People needed

112

Starts

2025-08-05

Expected to finish

2029-03-01

Last updated by the study team

2026-04-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet DSM-5 criteria for MDD of at least moderate severity (MADRS≥20).
• Participants either currently do not use antidepressants or are treated with a stable dose for at least 4 weeks prior to randomization.
• Age ≥ 21 years old.
• Sufficient understanding of the German language.
• Able to understand the study procedures and risks and willing to adhere to the protocol and sign the consent form.
• Willing not to drive or operate heavy machinery on the treatment day.
• 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.
• Willing to use effective contraceptive measures throughout study participation.

You may not qualify if…

• Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features.
• First-degree relative with a psychotic or bipolar disorder.
• Significant prodromal psychotic symptoms (Prodromal Questionnaire-16 symptoms ≥ 6).
• 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.
• Current post-traumatic stress disorder or acute stress reaction due to a traumatic event.
• Post-partum depression.
• Pregnant or breastfeeding women.
• Current or recent history of significant suicide ideation or suicide behavior within the past 6 months.
• Current severe substance use disorder other than nicotine.
• Planned ketamine, other psychedelic, or electroconvulsive treatment or any such treatment within the past 3 months.
• 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.
• 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.
• Increased risk for adverse reactions to propofol or soja products.
• Increased risk for aspiration.
• Increased risk for difficult mask ventilation.

Where it is running

• University Hospital Basel — Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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