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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06094907
Other study ID # DMTPRD
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 9, 2023
Est. completion date March 30, 2024

Study information

Verified date May 2024
Source Universidade Federal do Rio Grande do Norte
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date March 30, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Hospital Universitário Onofre Lopes Natal RN

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Systolic Blood Pressure Assessed 7 times on each session up to 2 hours
Other Diastolic Blood Pressure Assessed 7 times on each session up to 2 hours
Other Heart rate Assessed 7 times on each session up to 2 hours
Other Respiratory rate Assessed 7 times on each session up to 2 hours
Other Oxygen saturation Assessed 7 times on each session up to 2 hours
Other Plasma level of C-reactive protein (CRP) Assessed 2 times on each session up to 2 hours
Other Plasma level of cortisol Assessed 2 times on each session up to 2 hours
Other Plasma level of brain derived neurotrophic factor Assessed 2 times on each session up to 2 hours
Other Plasma level of glucose Assessed 2 times on each session up to 2 hours
Other Plasma level of total cholesterol Assessed 2 times on each session up to 2 hours
Other Plasma level of urea Assessed 2 times on each session up to 2 hours
Other Plasma level of creatinine Assessed 2 times on each session up to 2 hours
Other Plasma level of aspartate transaminase (AST) Assessed 2 times on each session up to 2 hours
Other Plasma level of alanine transaminase (ALT) Assessed 2 times on each session up to 2 hours
Other Evaluate the subjective effects of DMT 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
Other Evaluate the mystical effects of DMT 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
Other Evaluate the influence of expectations on improvement in depressive symptoms 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
Other Evaluate the influence of personality trait, by BFI (Big Five Inventory) 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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