DMT for Depression

Overseen By Leigh T Flynn, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Disqualifiers: Unstable medical conditions, Psychiatric illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug DMT for depression?

In a small study, DMT was found to be mostly safe and well-tolerated, showing potential rapid antidepressant effects in patients with treatment-resistant major depressive disorder, as their depression scores improved significantly the day after receiving the drug. ^{1 2 3 4 5}

Is DMT safe for use in humans?

In a small study, DMT was mostly safe and tolerated by participants, with mild side effects like increased blood pressure and heart rate that resolved quickly. There were no serious adverse events reported in other studies of similar psychedelic substances. ^{1 2 3 5 6}

How is the drug DMT unique in treating depression?

DMT is unique because it is a fast-acting psychedelic drug that is administered intravenously and may provide rapid antidepressant effects, showing significant improvement in depression symptoms the day after treatment. Unlike traditional antidepressants that can take weeks to work, DMT's effects are observed quickly, making it a novel option for treatment-resistant depression. ^{1 2 3 5 7}

Eligibility Criteria

This trial is for people who are mentally and physically healthy, without any major depressive disorder or other psychiatric conditions. It's designed to see if DMT can be safe and effective for those not currently experiencing depression.

Inclusion Criteria

People who are in good health and not participating as patients.

I am in good health.

You have no psychiatric disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation Treatment

Participants receive escalating doses of DMT administered intravenously to assess safety and efficacy

1 day per dose level

Multiple visits for each dose level

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dimethyltryptamine (DMT)

Trial Overview The study is testing two different doses of Dimethyltryptamine (DMT), a psychedelic compound: one lower dose at 0.1 mg/kg and a higher dose at 0.3 mg/kg, to understand its effects on humans in a controlled setting.

Participant Groups

Group I: 0.1 mg/kg DMT Active Control 1 Intervention

0.1 mg/kg DMT administered intravenously

Group II: 0.3 mg/kg DMT Active Control 1 Intervention

0.3 mg/kg DMT administered intravenously

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Findings from Research

In a small exploratory phase 1 study involving 10 participants (7 with major depressive disorder and 3 healthy controls), intravenous DMT was found to be mostly safe and well-tolerated, with no dropouts and only mild adverse events reported.

Participants with treatment-resistant major depressive disorder experienced a significant reduction in depression symptoms the day after receiving a 0.3 mg/kg dose of DMT, indicating potential rapid antidepressant effects that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder. D'Souza, DC., Syed, SA., Flynn, LT., et al.[2023]

In a survey of 362 participants who used 5-MeO-DMT in a structured group setting, 80% of those with depression and 79% with anxiety reported improvements in their conditions after use, suggesting potential therapeutic effects.

The improvements in depression and anxiety were linked to the intensity of mystical experiences and the perceived spiritual significance of the 5-MeO-DMT experience, rather than the challenging effects during the experience, indicating a unique mechanism of action that warrants further clinical investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) used in a naturalistic group setting is associated with unintended improvements in depression and anxiety. Davis, AK., So, S., Lancelotta, R., et al.[2020]

The psychedelic drug 5-MeO-DMT (GH001) was well tolerated in a study of 16 adults with treatment-resistant depression (TRD), showing significant safety in its administration.

In the Phase 2 trial, an individualized dosing regimen led to an impressive 87.5% remission rate by day 7, demonstrating potent and ultra-rapid antidepressant effects compared to lower remission rates in the single-dose groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression. Reckweg, JT., van Leeuwen, CJ., Henquet, C., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Exploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder. [2023]

2. England pubmed.ncbi.nlm.nih.gov

5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) used in a naturalistic group setting is associated with unintended improvements in depression and anxiety. [2020]

3. France pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of N,N-dimethyltryptamine in Humans. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Psychedelic therapy for depressive symptoms: A systematic review and meta-analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential Role of Serotonergic Hallucinogens in Depression Treatment. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of N, N-Dimethyltryptamine on Rat Behaviors Relevant to Anxiety and Depression. [2020]