Status:
RECRUITING
Antidepressant Response of DMT Masked With Propofol
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Major Depressive Disorder
Psychedelic Experiences
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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...
Detailed Description
Major depressive disorder (MDD) affects nearly 20% of people, but current treatments-both pharmacological and psychotherapeutic-have limited efficacy, especially for mild to severe cases. Psychedelics...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06927076
Start Date
August 5 2025
End Date
March 1 2029
Last Update
August 12 2025
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031