Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
112 participants
INTERVENTIONAL
2025-08-05
2029-03-31
Brief Summary
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Detailed Description
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This study aims to determine if the antidepressant effects of DMT occur independently of its psychedelic experience. To test this, DMT will be administered under sedation (with propofol) to mask subjective effects, as well as without sedation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DMT without sedation
DMT without sedation (propofol)
N,N-Dimethyltryptamine
administration of a 2mg/min DMT perfusion over 20 min
no sedation
no sedation
DMT with sedation
DMT with sedation (propofol)
N,N-Dimethyltryptamine
administration of a 2mg/min DMT perfusion over 20 min
Propofol
30 min propofol sedation
Placebo without sedation
Placebo (double-blind) without sedation (propofol)
Placebo
administration of a placebo perfusion over 20 min
no sedation
no sedation
Placebo with sedation
Placebo (double-blind) with sedation (propofol)
Placebo
administration of a placebo perfusion over 20 min
Propofol
30 min propofol sedation
Interventions
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N,N-Dimethyltryptamine
administration of a 2mg/min DMT perfusion over 20 min
Placebo
administration of a placebo perfusion over 20 min
Propofol
30 min propofol sedation
no sedation
no sedation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Matthias Liechti, Prof. Dr. med.
Role: STUDY_DIRECTOR
University Hospital, Basel, Switzerland
Felix Müller, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-02312;am24Liechti6
Identifier Type: -
Identifier Source: org_study_id
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