DMT for depression with psychedelic effects masked by propofol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with moderate-to-severe major depressive disorder will receive DMT under propofol sedation, DMT without sedation, or placebo, with mood assessed over follow-up. The trial will collect biological measures related to neuroplasticity and inflammation alongside standardized depression scales (e.g., MADRS) to link clinical effects with biological changes or subjective experience. Eligible participants are adults (≥21) who can consent, speak German, and are either medication-free or on a stable antidepressant dose; dosing and monitoring occur in a medical setting. All treatment visits are conducted in-person with medical monitoring at the study site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must meet DSM-5 criteria for MDD of at least moderate severity (MADRS≥20).
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:

1. Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features.
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.

Where it's running

• University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Felix Müller, PD Dr. med. — University Hospital, Basel, Switzerland
• Study coordinator: Joyce Santos de Jesus
• Email: DMT4D@usb.ch
• Phone: +41 61 556 65 02

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dupilumab for Major Depressive Disorder

  This study tests whether dupilumab can engage immune targets in adults with major depressive disorder to see if it can help with depressive symptoms.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07908563

• Accelerated vs Standard iTBS for Major Depression

  This trial tests whether giving more accelerated iTBS sessions is better tolerated and more effective than the standard schedule for adults with major depressive disorder.

  Recruiting Military Hospital 175 · Ho Chi Minh City · NCT07768397

• Psilocybin with Structured Integrated Reframing Therapy for trauma-related MDD and PTSD

  This trial tests whether psilocybin therapy, alone or with Structured Integrated Reframing Therapy (SIRT), helps people with trauma-related major depressive disorder who are already on a stable antidepressant.

  Recruiting Phase 3 Khyber Medical University Peshawar · Islamabad, Capital and 2 other locations · NCT07703722

• Magnesium Bisglycinate Added to Your Depression Treatment

  This study tests whether adding magnesium bisglycinate to your current antidepressant can help reduce depressive symptoms and improve sleep and daily functioning for adults with major depressive disorder.

  Recruiting All India Institute of Medical Sciences, Bhubaneswar · Bhubaneswar, Odisha · NCT07633080

• Motif XCS System for treatment-resistant depression

  This study tests whether the Motif XCS System is safe and tolerable and might help people with treatment-resistant major depressive disorder.

  Recruiting at 4 sites Motif Neurotech, Inc. · Atlanta, Georgia and 3 other locations · NCT07594483

• A Phase 3 test of DT120 for major depressive disorder

  DT120 is tested against placebo in adults with major depressive disorder to see if it can help reduce depressive symptoms.

  Recruiting at 23 sites Phase 3 Definium Therapeutics US, Inc. · Little Rock, Arkansas and 25 other locations · NCT07592689

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.