BridgeMD
Tests treatment safety and results for Major Depression Disorder
Official title Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
ClinicalTrials.gov ID: NCT06671977
What this study is testing
What is DMT-Medium Dose?
DMT-Medium Dose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for major depression disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this phase 1 study is to investigate the safety and efficacy of dimethyltryptamine (DMT) in individuals with depression and healthy controls. We hypothesize that administration of DMT will result in decreases in depression, associated symptoms, and neuroplastic changes in depressed subjects.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Some Common
- Males and females
- Age 21 to 65 years
- Body mass index between 18-35 kg/m2
- Willing to refrain from taking any medications not approved by the study physician
You likely can't join if
- Medications that might significantly interfere with the effects of the study medications
- Cognitive dysfunction that could interfere with study participation
- Alcohol or substance use disorder
- Any lifetime history of hallucinogen use disorder
- Regular use or misuse of hallucinogens
- History of intolerance to perceptual altering drugs
See the full eligibility criteria
- Some Common
- Males and females
- Age 21 to 65 years
- Body mass index between 18-35 kg/m2
- Willing to refrain from taking any medications not approved by the study physician
- Willing to refrain from using street drugs and alcohol
- Negative urine drug screen
- Willing and able to abstain from smoking throughout each test session
- Women who are of child-bearing potential (WOCBP) and sexually active must be willing to practice an effective means of birth control
- Willing not to drive to and from the testing session Some for people with MDD:
- Diagnosed with Major Depressive Disorder (MDD)
- Unsatisfactory response to antidepressants
- Engaged in treatment for depression with a clinician and willing to continue treatment for the duration of the study
- Not engaged in treatment
- Consent to allow the research team to communicate with mental health provider.
- Only people who get support for participation in the trial from their mental health clinician will be eligible to be enrolled in the study Some Common
- Medications that might significantly interfere with the effects of the study medications
- Cognitive dysfunction that could interfere with study participation
- Alcohol or substance use disorder
- Any lifetime history of hallucinogen use disorder
- Regular use or misuse of hallucinogens
- History of intolerance to perceptual altering drugs
- Significant blood pressure problems
- Pregnancy or currently breast feeding (lactation)
- Any unstable medical conditions
- Significant cardiovascular disease
- Significantly abnormal laboratory test results
- History of serotonin syndrome Some Exclusion criteria for MDD people:
- Current primary psychiatric disorder other than MDD
- Medically significant condition rendering unsuitability for the study Some Exclusion criteria for healthy controls:
- No current DSM-V psychiatric disorder, excluding nicotine and caffeine use disorder
- No family history of serious mental illness (e.g., schizophrenia, bipolar disorder) Some Inclusion criteria for healthy controls:
- No current DSM-5 psychiatric disorder, excluding nicotine and caffeine use disorder
- No lifetime use of psychiatric medication \>3 months (proxy for psychiatric disorders)
The study team makes the final eligibility decision.
Where it's taking place
- West Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.