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

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

N,N-Dimethyltryptamine

About this trial

This is an interventional treatment trial for Depressive Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Universitário Onofre LopesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

N,N-Dimethyltryptamine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT06094907

First Posted

October 10, 2023

Last Updated

October 17, 2023

Sponsor

Universidade Federal do Rio Grande do Norte

1. Study Identification

Unique Protocol Identification Number

NCT06094907

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 9, 2023 (Actual)

Primary Completion Date

January 15, 2024 (Anticipated)

Study Completion Date

March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Depression, Unipolar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

N,N-Dimethyltryptamine

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

N,N-Dimethyltryptamine

Other Intervention Name(s)

DMT

Intervention Description

DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg.

Primary Outcome Measure Information:

Title

Change in MADRS scores

Description

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.

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Change in PHQ-9 scores

Description

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.

Time Frame

7 days

Title

Change in BSI scores.

Description

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.

Time Frame

1 day

Title

Change in MADRS scores 14 days

Description

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.

Time Frame

14 days

Title

Change in MADRS scores 1 month

Description

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.

Time Frame

1 month

Title

Change in MADRS scores 3 months

Description

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.

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Systolic Blood Pressure

Description

Assessed 7 times on each session

Time Frame

up to 2 hours

Title

Diastolic Blood Pressure

Description

Assessed 7 times on each session

Time Frame

up to 2 hours

Title

Heart rate

Description

Assessed 7 times on each session

Time Frame

up to 2 hours

Title

Respiratory rate

Description

Assessed 7 times on each session

Time Frame

up to 2 hours

Title

Oxygen saturation

Description

Assessed 7 times on each session

Time Frame

up to 2 hours

Title

Plasma level of C-reactive protein (CRP)

Description