Actively Recruiting
Antidepressant Response of DMT Masked With Propofol
Led by University Hospital, Basel, Switzerland · Updated on 2026-04-02
112
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Antidepressant Response of DMT Masked With Propofol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet DSM-5 criteria for moderate or more severe Major Depressive Disorder (MADRS 420).
- Participants either do not use antidepressants or have been on a stable antidepressant dose for at least 4 weeks before randomization.
- Participants must be 21 years old or older.
- Must have sufficient understanding of the German language.
- Must understand study procedures and risks and be willing to follow the protocol and sign consent.
- Must agree not to drive or operate heavy machinery on the treatment day.
- Must agree to limit alcohol to 7 standard drinks per week, smoking to 10 cigarettes per day, coffee to 2 cups per day, and avoid illicit drugs during study participation.
- Must agree to use effective contraception throughout the study.
You will not qualify if you...
- Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features.
- First-degree relative with psychotic or bipolar disorder.
- Significant prodromal psychotic symptoms (Prodromal Questionnaire-16 score 46).
- Psychiatric conditions incompatible with safe DMT exposure, such as borderline personality disorder.
- Current post-traumatic stress disorder or acute stress reaction.
- Post-partum depression.
- Pregnant or breastfeeding women.
- Significant suicidal thoughts or behaviors within past 6 months.
- Severe substance use disorder other than nicotine.
- Planned or recent ketamine, psychedelic, or electroconvulsive treatment within past 3 months.
- Lifetime use of DMT or more than 15 lifetime uses of other psychedelics.
- Use of neuroleptics, 5-HT2 receptor antagonists, or MAO inhibitors without ability or willingness to pause treatment.
- Increased risk for adverse reactions to propofol or soy products.
- Increased risk for aspiration.
- Increased risk for difficult mask ventilation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
J
Joyce Santos de Jesus
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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