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

Universidade Federal do Rio Grande do Norte

Status and phase: Completed; Phase 2

Conditions: Depression, Unipolar; Depressive Disorder

Treatments: Drug: N,N-Dimethyltryptamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06094907

DMTPRD

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

N,N-Dimethyltryptamine

Experimental group

Description:

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.

Treatment:

Drug: N,N-Dimethyltryptamine