NCT06094907

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Universidade Federal do Rio Grande do Norte · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder
• Depression, Unipolar

Interventions

Type	Name	Description
DRUG	N,N-Dimethyltryptamine	DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg.

Timeline

• Start date: 2023-10-09
• Primary completion: 2024-01-15
• Completion: 2024-03-30
• First posted: 2023-10-23
• Last updated: 2024-05-08

Locations

1 site across 1 country: Brazil