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

• Status: Completed
• Trial end date: 2024-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal do Rio Grande do Norte
• Treatments: N,N-Dimethyltryptamine

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