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Recruiting NCT06927076

Antidepressant Response of DMT Masked With Propofol

No phase Interventional Major Depressive Disorder Psychedelic Experiences

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N,N-Dimethyltryptamine, Placebo, Propofol, no sedation.
Who it may be relevant to
Registry conditions: Major Depressive Disorder, Psychedelic Experiences. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

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 like LSD, psilocybin, and DMT are being explored as alternative therapies, with studies showing promising antidepressant effects. However, it is unclear whether these benefits stem from their acute subjective (psychedelic) experience or from biological mechanisms like neuroplasticity and anti-inflammatory effects.

This study aims to determine if the antidepressant effects of DMT occur independently of its psychedelic experience. To test this, DMT will be administered under sedation (with propofol) to mask subjective effects, as well as without sedation.

Interventions

  • Drug N,N-Dimethyltryptamine
    administration of a 2mg/min DMT perfusion over 20 min
  • Drug Placebo
    administration of a placebo perfusion over 20 min
  • Procedure Propofol
    30 min propofol sedation
  • Procedure no sedation
    no sedation

Primary outcome measures

  • long term changes in depressive symptoms (MADRS) [Time frame: baseline (before intervention) and on day 14 post-intervention]
Secondary outcome measures (12)
  • Short term changes in depressive symptoms (MADRS) [Time frame: Baseline (before intervention) and on day 1, 3 and 7 post-intervention]
  • Changes in depressive symptoms (BDI) [Time frame: Baseline (before intervention) and on day 1, 3, 7 and 14 post-intervention]
  • Changes in anxiety (STAI) [Time frame: Baseline (before intervention) and on day 1, 3, 7 and 14 post-intervention]
  • Changes of clinical global impression (CGI-S) [Time frame: Baseline (before intervention) and on day 1, 3, 7 and 14 post-intervention]
  • Changes of clinical global impression (CGI-I) [Time frame: Baseline (before intervention) and on day 1, 3, 7 and 14 post-intervention]
  • Changes in quality of life (WHOQOL-bref) [Time frame: Baseline (before intervention) and on day 1, 3, 7 and 14 post-intervention]
  • Persisting positive and negative effects (PEQ) [Time frame: On day 14 post-intervention]
  • Acute subjective effects (5D-ASC) [Time frame: On day 0 post-intervention]
  • Subjective Effects Rating (SES) [Time frame: On day 0 pre- and post-intervention]
  • Psychedelic Experience Scale (PES) [Time frame: On day 0 post-intervention]
  • Emotional breakthrough inventory (EBI) [Time frame: On day 0 post-intervention]
  • Acute adverse effects [Time frame: On day 0 and 1 post-intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT06927076 · 2024-02312;am24Liechti6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗