Antidepressant Response of DMT Masked With Propofol
Recruiting · NCT06927076 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
N,N-DimethyltryptaminePlaceboPropofolno sedation
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.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- University Hospital Basel - Basel, Switzerland