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

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06094907
• Other study ID #: DMTPRD
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depression, Unipolar
• Depressive Disorder

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