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

May 6, 2024 updated by: Draulio Barros de Araujo, Universidade Federal do Rio Grande do Norte

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • RN
      • Natal, RN, Brazil, 59012300
        • Hospital Universitário Onofre Lopes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: N,N-Dimethyltryptamine
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
DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg.
Other Names:
  • DMT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in MADRS scores
Time Frame: 7 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in PHQ-9 scores
Time Frame: 7 days
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.
Time Frame: 1 day
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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: up to 2 hours
Assessed 7 times on each session
up to 2 hours
Diastolic Blood Pressure
Time Frame: up to 2 hours
Assessed 7 times on each session
up to 2 hours
Heart rate
Time Frame: up to 2 hours
Assessed 7 times on each session
up to 2 hours
Respiratory rate
Time Frame: up to 2 hours
Assessed 7 times on each session
up to 2 hours
Oxygen saturation
Time Frame: up to 2 hours
Assessed 7 times on each session
up to 2 hours
Plasma level of glucose
Time Frame: up to 2 hours
Assessed 2 times on each session
up to 2 hours
Plasma level of total cholesterol
Time Frame: up to 2 hours
Assessed 2 times on each session
up to 2 hours
Plasma level of C-reactive protein (CRP)
Time Frame: up to 2 hours
Assessed 2 times on each session
up to 2 hours
Plasma level of urea
Time Frame: up to 2 hours
Assessed 2 times on each session
up to 2 hours
Plasma level of creatinine
Time Frame: up to 2 hours
Assessed 2 times on each session
up to 2 hours
Plasma level of aspartate transaminase (AST)
Time Frame: up to 2 hours
Assessed 2 times on each session
up to 2 hours
Plasma level of alanine transaminase (ALT)
Time Frame: up to 2 hours
Assessed 2 times on each session
up to 2 hours
Plasma level of cortisol
Time Frame: up to 2 hours
Assessed 2 times on each session
up to 2 hours
Plasma level of brain derived neurotrophic factor
Time Frame: up to 2 hours
Assessed 2 times on each session
up to 2 hours
Evaluate the subjective effects of DMT
Time Frame: up to 2 hours
Assessment of the acute subjective effects of DMT, by 5D-ASC (5 Dimensions - Altered States of consciousness). Scores range from 0 to 94, where higher scores indicate more intense psychedelic subjective effects.
up to 2 hours
Evaluate the mystical effects of DMT
Time Frame: up to 2 hours
Assessment of the acute subjective effects of DMT, by MEQ (Questionnaire of Mystical Experiences). Scores range from 0 to 150, where higher scores indicate more intense psychedelic subjective effects.
up to 2 hours
Evaluate the influence of expectations on improvement in depressive symptoms
Time Frame: up to 0.5 hours
Assessment of the influence of patient's expectations on improvement in depressive symptoms as measured by a 5 point likert scale range from: nothing to extreme.
up to 0.5 hours
Evaluate the influence of personality trait, by BFI (Big Five Inventory)
Time Frame: up to 3 months
Assessment of the influence of personality trait assessed by the 44-item Big Five Inventory that measures an individual on the Big Five Factors (dimensions) of personality on depressive symptoms. The 5 dimensions are: Extraversion vs. introversion; Agreeableness vs. antagonism; Conscientiousness vs. lack of direction; Neuroticism vs. emotional stability; Openness vs. closedness to experience.
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Rio Grande do Norte

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Draulio Araujo, Ph.D, Universidade Federal do Rio Grande do Norte
  • Study Director: Marcelo Falchi, M.D., Universidade Federal do Rio Grande do Norte
  • Study Director: Fernanda Palhano-Fontes, Ph.D, Universidade Federal do Rio Grande do Norte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMTPRD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings