Antidepressant Response of DMT Masked With Propofol
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
N,N-Dimethyltryptamine
Drugadministration of a 2mg/min DMT perfusion over 20 min
Placebo
Drugadministration of a placebo perfusion over 20 min
Propofol
Procedure/Surgery30 min propofol sedation
no sedation
Procedure/Surgeryno sedation
Treatment groups
112 Participants
are divided into 4 treatment groupsGroup A: DMT without sedationExperimental treatment 2 interventions
Group B: DMT with sedationExperimental treatment 2 interventions
Group C: Placebo without sedationPlacebo comparator 2 interventions
Group D: Placebo with sedationPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
long term changes in depressive symptoms (MADRS)
Changes in depressive symptoms will be assessed using Montgomery-Asberg-Depression Rating Scale (MADRS). The MADRS is a ten-item questionnaire widely used to measure severity of depressive symptoms during the last week. Total score (range 0-60); higher scores indicate greater depression severity.
Time frame
baseline (before intervention) and on day 14 post-interventionSecondary outcomes
1
Short term changes in depressive symptoms (MADRS)
Changes in depressive symptoms will be assessed using Montgomery-Asberg-Depression Rating Scale (MADRS). The MADRS is a ten-item questionnaire widely used to measure severity of depressive symptoms during the last week. Total score (range 0-60); higher scores indicate greater depression severity.
Time frame
Baseline (before intervention) and on day 1, 3 and 7 post-intervention2
Changes in depressive symptoms (BDI)
Changes in depressive symptoms will be assessed using Beck Depression Inventory (BDI) questionnaire. Total score (range 0-63); higher scores indicate more severe depressive symptoms.
Time frame
Baseline (before intervention) and on day 1, 3, 7 and 14 post-intervention3
Changes in anxiety (STAI)
Changes in anxiety will be assessed using the self-reported State-Trait Anxiety Inventory (STAI) questionnaire. Separate total scores for State Anxiety (S-Anxiety) and Trait Anxiety (T-Anxiety) (each range 20-80); higher scores indicate greater anxiety.
Time frame
Baseline (before intervention) and on day 1, 3, 7 and 14 post-intervention4
Changes of clinical global impression (CGI-S)
The clinical global impression (CGI) is an instrument for the assessment of the patient's overall functioning both before and after starting the treatment. Severity of Illness (CGI-S): Rated on a 7-point scale (1 = normal, 7 = among the most extremely ill).
Time frame
Baseline (before intervention) and on day 1, 3, 7 and 14 post-interventionSponsors and contacts
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Source ClinicalTrials.gov