Clinical Study of GH001 in Depression

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.

Topic Treatment-Resistant Depression
Compound 5-MeO-DMT
Country Netherlands
Visit trial
Status Completed
Results Published No
Start date 12 November 2019
End date 01 September 2021
Chance of happening 100%
Phase Phase I Phase II
Design Open
Type Interventional
Generation Second
Participants 15
Sex All
Age 18- 64
Therapy No

Trial Details

Phase 1 (Part A): The primary objective of this study is to assess the safety and tolerability of single doses of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT) in patients with TRD. The secondary objectives of the study are to assess the effects of single doses of GH001 on various measures of depression, and on dose-related psychoactive effects. Phase 2 (Part B): The primary objective of this study is to assess the effects of an individualized dosing regimen of GH001 on the severity of depression. The secondary objectives of the study are to assess the safety and tolerability of an individualized dosing regimen of GH001 in patients with TRD and its effects on the severity of depression, other measures of depression, and on dose-related psychoactive effects. Study design: Phase 1/2 study in two parts. Intervention: In the Phase 1 (Part A), a single dose of GH001 will be administered per patient. Two different dose levels will be investigated with four patients at each dose level. In the Phase 2 (Part B), an individualized dosing regimen will be administered. In both parts, GH001 will be administered via inhalation.

NCT Number NCT04698603

Sponsors & Collaborators

GH Research
GH Research is developing several 5-MeO-DMT based therapeutic mechanisms for various mental health disorders.

Papers

A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression
This two-part clinical trial (n=16) investigated the safety and potential antidepressant effects of vaporized 5-MeO-DMT (GH001) in patients with treatment-resistant depression (TRD). Phase I (n=8) tested two single doses (12mg and 18mg) for safety, while Phase II (n=8) evaluated an individualized dosing regimen with up to three increasing doses (6mg, 12mg, 18mg) in a single day for efficacy. The results showed GH001 was well-tolerated and had potent and rapid antidepressant effects, with 87.5% of patients in the Phase 2 group achieving remission by day seven.

Data attribution

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