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New treatment option for Major Depressive Disorder
Official title Antidepressant Response of DMT Masked With Propofol
ClinicalTrials.gov ID: NCT06927076
What this study is testing
What is N,N-Dimethyltryptamine?
N,N-Dimethyltryptamine is an investigational medicine, being studied as a potential treatment for major depressive disorder.
Also referred to as DMT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Current post-traumatic stress disorder or acute stress reaction due to a traumatic event.
- Post-partum depression.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.