Clinical TrialMajor Depressive Disorder (MDD)DMTDMTActive not recruiting

Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans

Fixed-order, open-label, dose-escalation interventional study (n=30 estimated) testing two IV DMT doses (0.1 mg/kg and 0.3 mg/kg) in healthy and depressed participants to assess safety and dose-related neurophysiological effects.

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Target Enrollment
30 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This fixed-order, open-label study administers two IV doses of DMT (0.1 mg/kg then 0.3 mg/kg) across two test days in healthy volunteers and participants with major depressive disorder to characterise safety and inform dosing for a subsequent double-blind, randomized, placebo-controlled crossover trial.

Neuroplastic and mood-related effects will be indexed using EEG measures and psychometric assessments; outcomes will guide dose selection for future efficacy studies.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

0.1 mg/kg DMT

active comparator

0.1 mg/kg DMT intravenous fixed-order test day.

Interventions

  • DMT0.1 mg/kg
    via IV• single dose• 1 doses total

    Low dose (0.1 mg/kg) administered IV on test day 1.

0.3 mg/kg DMT

active comparator

0.3 mg/kg DMT intravenous fixed-order test day.

Interventions

  • DMT0.3 mg/kg
    via IV• single dose• 1 doses total

    Moderate dose (0.3 mg/kg) administered IV on test day 2.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Healthy controls inclusion criteria:
  • Medically healthy
  • Psychiatrically healthy
  • Depression inclusion criteria:
  • Medically healthy
  • Diagnosis of major depressive disorder

Exclusion Criteria

  • Healthy controls exclusion criteria:
  • Unstable medical conditions
  • Psychiatric illness
  • Depression exclusion criteria:
  • Unstable medical conditions

Study Protocol, Arms & Participants

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Study Details

  • Status
    Active not recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment30 participants
  • Timeline
    Start: 2021-03-17
    End: 2022-06-01
  • Compounds
    DMTDMT
  • Topic
    Major Depressive Disorder (MDD)

Study Team

Sponsors & Collaborators

Locations

Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine — West Haven, Connecticut, United States

Related Publications

Open AccessindividualPrimary

Exploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder

This open-label study assessed the safety, tolerability, and efficacy of intravenous DMT (70mg/70kg followed by 210mg/70kg) in healthy participants (n=3) and participants with treatment-resistant major depressive disorder (n=7). DMT was well-tolerated in both groups while depression scores decreased significantly the day after receiving the high dose. Adverse events were mostly mild and were resolved within 20-30 minutes of injection.

Published
Journal
Neuropsychopharmacology
Authors
D’Souza, D. C., Syed, S. A., Safi-Aghdam, H., Cozzi, N. V., Ranganathan, M.

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