Investigating the effects of DMT on depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 study aims to evaluate the safety and efficacy of dimethyltryptamine (DMT) in individuals diagnosed with Major Depressive Disorder (MDD) as well as healthy controls. The study hypothesizes that DMT administration will lead to reductions in depressive symptoms and promote neuroplastic changes, which will be assessed through electroencephalographic (EEG) measures and psychometric evaluations. Participants will receive varying doses of DMT and THC to compare their effects on mood and brain activity. The study will include both depressed individuals and healthy volunteers to understand the differential impact of DMT.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Principal investigator: Deepak D'Souza, MD — Yale University
• Study coordinator: Deepak C D'Souza, MD
• Email: deepak.dsouza@yale.edu
• Phone: (203) 932-5711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.