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Completed

NCT Number: NCT06094907

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

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Key information

Conditions

Depressive Disorder Depression, Unipolar Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, 59012300, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N,N-Dimethyltryptamine

Drug

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

Other names: DMT

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. Systolic Blood Pressure

    Time frame: up to 2 hours

    Assessed 7 times on each session

  2. Diastolic Blood Pressure

    Time frame: up to 2 hours

    Assessed 7 times on each session

  3. Heart rate

    Time frame: up to 2 hours

    Assessed 7 times on each session

  4. Respiratory rate

    Time frame: up to 2 hours

    Assessed 7 times on each session

  5. Oxygen saturation

    Time frame: up to 2 hours

    Assessed 7 times on each session

  6. Plasma level of C-reactive protein (CRP)

    Time frame: up to 2 hours

    Assessed 2 times on each session

  7. Plasma level of cortisol

    Time frame: up to 2 hours

    Assessed 2 times on each session

  8. Plasma level of brain derived neurotrophic factor

    Time frame: up to 2 hours

    Assessed 2 times on each session

  9. Plasma level of glucose

    Time frame: up to 2 hours

    Assessed 2 times on each session

  10. Plasma level of total cholesterol

    Time frame: up to 2 hours

    Assessed 2 times on each session

  11. Plasma level of urea

    Time frame: up to 2 hours

    Assessed 2 times on each session

  12. Plasma level of creatinine

    Time frame: up to 2 hours

    Assessed 2 times on each session

  13. Plasma level of aspartate transaminase (AST)

    Time frame: up to 2 hours

    Assessed 2 times on each session

  14. Plasma level of alanine transaminase (ALT)

    Time frame: up to 2 hours

    Assessed 2 times on each session

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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