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
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Trial Details



Trial Number

Sponsors & Collaborators

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

Papers

Evaluation of the peak experience scale as a rapid assessment tool for the strength of a psychoactive experience with 5-MeO-DMT
This data analysis of three studies (n=84) validates a three-item Peak Experience Scale (PES) for rapidly assessing 5-MeO-DMT experiences, demonstrating that the scale shows strong internal consistency (Cronbach's α=0.896), correlates highly with established psychedelic experience measures (MEQ-30, EDI, 5D-ASC), and could effectively guide dosing regimens for rapid-acting psychedelics.

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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