Dimethyltryptamine molecule:

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DMT Clinical Trials

A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression

To see complete record on clinicaltrials.gov, please visit this link

Id: NCT04698603

Organisation Name: GH Research Ireland Limited

Overal Status: Completed

Start Date: November 12, 2019

Last Update: December 20, 2021

Lead Sponsor: GH Research Ireland Limited

Brief Summary: The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of depressive symptoms, and its dose-related psychoactive effects in patients with Treatment-Resistant Depression (TRD).

The study is comprised of two open-label, single-arm study parts where Part A evaluates single doses of GH001 at two dose levels and Part B evaluates a specific individualized dosing regimen of GH001.

  • Treatment Resistant Depression
  • Major Depressive Disorder
  • Depression

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