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Psychedelic

DMT for Depression (DMT-Bolus Trial)

Phase 1

Waitlist Available

Led By Deepak D'Souza, MD

Research Sponsored by Deepak C. D'Souza

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females aged 21 to 65 years

Willing to refrain from taking any medications not approved by the study physician

Must not have

Cognitive dysfunction that could interfere with study participation

First degree relatives with a history of psychosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: -60 and -30 minutes before dmt administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after dmt administration]blood pressure and heart rate will be measured before, during, and after the dosing on each test day.

Summary

This trial aims to study the effects of a substance called dimethyltryptamine (DMT) on people with depression and those without depression. The researchers believe that DMT may help reduce depression symptoms

Who is the study for?

This trial is for individuals with depression, including major depression. It's also open to healthy people as a control group. Participants must meet specific health requirements and be willing to undergo EEG measures and mood assessments.

What is being tested?

The study tests the effects of two doses each of DMT and THC on depression symptoms and brain changes. Researchers will use EEG to track neuroplasticity and psychometric tools to measure mood alterations in participants.

What are the potential side effects?

Possible side effects may include altered sensory experiences, changes in perception or reality, increased heart rate, coordination issues, anxiety, confusion, nausea, or headaches due to the psychoactive nature of DMT and THC.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

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I am willing to only take medications approved by the study doctor.

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I have been diagnosed with Major Depressive Disorder and am currently having a severe episode.

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I agree not to drive myself to and from the test sessions.

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I've tried at least one antidepressant for 6 weeks without enough improvement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any mental health issues that would prevent me from participating.

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I have a close family member with a history of psychosis.

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I have low blood pressure.

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I have never used psychiatric medication for more than 3 months.

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I do not have a family history of serious mental illness.

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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I have never had a psychotic disorder.

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I have a history of mania.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: -60 and -30 minutes before dmt administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after dmt administration]blood pressure and heart rate will be measured before, during, and after the dosing on each test day.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: -60 and -30 minutes before dmt administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after dmt administration]blood pressure and heart rate will be measured before, during, and after the dosing on each test day.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: -60 and -30 minutes before dmt administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after dmt administration]blood pressure and heart rate will be measured before, during, and after the dosing on each test day. for reporting.