Psychedelic DMT studied for depression relief in early human trial
NCT ID NCT06671977
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 1 study is testing the safety and brain effects of DMT, a psychedelic drug, in 60 adults with depression and healthy volunteers. Participants receive low or medium doses of DMT, THC, or a placebo, and researchers monitor mood, anxiety, and brain activity. The goal is to see if DMT can safely produce changes in the brain that might ease depression, but this is very early research and not a proven treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DMT (dimethyltryptamine), a psychedelic drug
- What this could lead to
- If successful, this could point toward a new, fast-acting treatment for depression that works by promoting brain changes.
- What could go wrong
- This is a very early Phase 1 study with only 60 participants, focused on safety and brain activity, not on proving depression relief. Psychedelic side effects like anxiety or challenging experiences are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Some Common Inclusion Criteria: 1. Males and females 2. Age 21 to 65 years 3. Body mass index between 18-35 kg/m2 4. Willing to refrain from taking any medications not approved by the study physician 5. Willing to refrain from using street drugs and alcohol 6. Negative urine drug screen 7. Willing and able to abstain from smoking throughout each test session 8. Women who are of child-bearing potential (WOCBP) and sexually active must be willing to practice an effective means of birth control 9. Willing not to drive to and from the testing session Some Inclusion Criteria for Subjects with MDD: 1. Diagnosed with Major Depressive Disorder (MDD) 2. Unsatisfactory response to antidepressants 3. Engaged in treatment for depression with a clinician and willing to continue treatment for the duration of the study 4. Not engaged in treatment 5. Consent to allow the research team to communicate with mental health provider. 6. Only subjects who get support for participation in the trial from their mental health clinician will be eligible to be enrolled in the study Some Common Exclusion Criteria: 1. Medications that might significantly interfere with the effects of the study medications 2. Cognitive dysfunction that could interfere with study participation 3. Alcohol or substance use disorder 4. Any lifetime history of hallucinogen use disorder 5. Regular use or misuse of hallucinogens 6. History of intolerance to perceptual altering drugs 7. Significant blood pressure problems 8. Pregnancy or currently breast feeding (lactation) 9. Any unstable medical conditions 10. Significant cardiovascular disease 11. Significantly abnormal laboratory test results 12. History of serotonin syndrome Some Exclusion criteria for MDD subjects: 1. Current primary psychiatric disorder other than MDD 2. Medically significant condition rendering unsuitability for the study Some Exclusion criteria for healthy controls: 1. No current DSM-V psychiatric disorder, excluding nicotine and caffeine use disorder 2. No family history of serious mental illness (e.g., schizophrenia, bipolar disorder) Some Inclusion criteria for healthy controls: 1. No current DSM-5 psychiatric disorder, excluding nicotine and caffeine use disorder 2. No lifetime use of psychiatric medication \>3 months (proxy for psychiatric disorders)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine,
RECRUITINGWest Haven, Connecticut, 06516, United States
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