Clinical trial NCT06094907: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Depression, Unipolar
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in MADRS scores
timeFrame: 7 days
Secondary outcomes:
measure: Change in PHQ-9 scores
timeFrame: 7 days
measure: Change in BSI scores.
timeFrame: 1 day
measure: Change in MADRS scores 14 days
timeFrame: 14 days
measure: Change in MADRS scores 1 month
timeFrame: 1 month
measure: Change in MADRS scores 3 months
timeFrame: 3 months
Other outcomes:
measure: Systolic Blood Pressure
timeFrame: up to 2 hours
measure: Diastolic Blood Pressure
timeFrame: up to 2 hours
measure: Heart rate
timeFrame: up to 2 hours
measure: Respiratory rate
timeFrame: up to 2 hours
measure: Oxygen saturation
timeFrame: up to 2 hours
measure: Plasma level of C-reactive protein (CRP)
timeFrame: up to 2 hours
measure: Plasma level of cortisol
timeFrame: up to 2 hours
measure: Plasma level of brain derived neurotrophic factor
timeFrame: up to 2 hours
measure: Plasma level of glucose
timeFrame: up to 2 hours
measure: Plasma level of total cholesterol
timeFrame: up to 2 hours
measure: Plasma level of urea
timeFrame: up to 2 hours
measure: Plasma level of creatinine
timeFrame: up to 2 hours
measure: Plasma level of aspartate transaminase (AST)
timeFrame: up to 2 hours
measure: Plasma level of alanine transaminase (ALT)
timeFrame: up to 2 hours
measure: Evaluate the subjective effects of DMT
timeFrame: up to 2 hours
measure: Evaluate the mystical effects of DMT
timeFrame: up to 2 hours
measure: Evaluate the influence of expectations on improvement in depressive symptoms
timeFrame: up to 0.5 hours
measure: Evaluate the influence of personality trait, by BFI (Big Five Inventory)
timeFrame: up to 3 months
Locations:
city: Natal
country: Brazil
facility: Hospital Universitário Onofre Lopes
state: RN
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Draulio Araujo, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio Grande do Norte
name: Marcelo Falchi, M.D.
role: STUDY_DIRECTOR
affiliation: Universidade Federal do Rio Grande do Norte
name: Fernanda Palhano-Fontes, Ph.D
role: STUDY_DIRECTOR
References: