Status:
ACTIVE_NOT_RECRUITING
Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans
Lead Sponsor:
Yale University
Conditions:
Major Depressive Disorder
Depression
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief Summary
The goal of this fixed order, open-label, dose-escalation study is to investigate the safety and efficacy of specific doses of dimethyltryptamine (DMT) in humans.
Detailed 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-bl...
Eligibility Criteria
Inclusion
- Healthy controls inclusion criteria:
- Medically healthy
- Psychiatrically healthy
- Healthy controls exclusion criteria:
- Unstable medical conditions
- Psychiatric illness
- Depression inclusion criteria:
- Medically healthy
- Diagnosis of major depressive disorder
- Depression exclusion criteria:
- Unstable medical conditions
Exclusion
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04711915
Start Date
March 17 2021
End Date
December 1 2026
Last Update
August 3 2025
Active Locations (1)
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1
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, United States, 06516