Investigating the Role of the Psychedelic Experience in the Antidepressant Response in Patients With Major Depression: a Placebo-controlled Factorial Trial With DMT Masked With Propofol (DMT4D-Study)
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.
• 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.