Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Depression
- Major Depressive Disorder
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Healthy individuals and patients with major depressive disorder will participate in this study. Subjects will receive 0.1 mg/kg and 0.3 mg/kg DMT in a fixed order across 2 test days.Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 21 years and 65 years
- Gender
- Both males and females
Description
The results of this study will inform the doses to be used in a larger, double-blind, randomized, placebo-controlled, crossover study. Since the goal of the open label study is to inform the double-blind, randomized, placebo-controlled study, the investigators are citing the hypothesis of the latter...
The results of this study will inform the doses to be used in a larger, double-blind, randomized, placebo-controlled, crossover study. Since the goal of the open label study is to inform the double-blind, randomized, placebo-controlled study, the investigators are citing the hypothesis of the latter solely for providing context. The investigators hypothesize that the administration of DMT will result in neuroplastic changes in healthy and depressed subjects. These changes in neuroplasticity will be indexed using electroencephalographic (EEG) measures and tasks. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.
Tracking Information
- NCT #
- NCT04711915
- Collaborators
- Not Provided
- Investigators
- Not Provided
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