Safety, Tolerability and Antidepressant Effects of DMT in Patients With Depression

Study Overview
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Brief Summary
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This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.

Detailed Description
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This is a phase II open-label, single-ascending, fixed-order study to assess the feasibility and efficacy of inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.

Official Title
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An Open Label Trial of Inhaled N,N-Dimethyltryptamine in Patients With Partial Response in Depression.

Conditions
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Depressive Disorder, Depression, Unipolar

Intervention / Treatment
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* Drug: N,N-Dimethyltryptamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in current treatment for depression with a partial response. Exclusion Criteria: heart failure liver failure kidney failure uncontrolled high blood pressure history of heart rhythm disorders history of valvular heart disease history of chronic obstructive pulmonary disease (COPD) active or in treatment for bronchial asthma severe obesity coagulation disorders clinical evidence or history of increased intracranial clinical evidence or history of cerebrospinal pressure history or reports of epilepsy severe neurological disease pregnancy reported or clinically recognized thyroid disorders diagnosis or family suspicion of genetic monoamine deficiency oxidase previous adverse response to psychedelic substances symptoms or family members with a present or past psychotic disorder dissociative identity disorder bipolar affective disorder prodromal symptoms of schizophrenia problematic use or abuse of alcohol or other psychoactive substances (except tobacco) acute or subacute risk of suicide acute flu symptoms symptoms of airway infection contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N,N-Dimethyltryptamine<br>Administration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 1-hour dose interval. | Drug: N,N-Dimethyltryptamine<br>* DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg.<br>* Other names: DMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MADRS scores | Change in MADRS scores from baseline to 7 days after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PHQ-9 scores | Change in PHQ-9 scores from baseline to 7 days after the dosing session. The Patient Health Questionnaire-9 (PHQ-9) is a questionnaire self-reported assessing the severity of the depression. The scale was in french and has 9 items, with an overall score ranging from 0 to 27 points. Higher score indicates more severe depression. | 7 days | 
| Change in BSI scores. | Change in BSI scores from baseline to 1 day after the dosing session. The Beck rating scale for suicidal ideation (BSI) is a 21-item self-report questionnaire. Each item is rated on a scale from 0 to 2, resulting in a total score ranging from 0 to 38. | 1 day | 
| Change in MADRS scores 14 days | Change in MADRS scores from baseline to 14 day after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression. | 14 days | 
| Change in MADRS scores 1 month | Change in MADRS scores from baseline to one month after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression. | 1 month | 
| Change in MADRS scores 3 months | Change in MADRS scores from baseline to three months after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression. | 3 months |