A Trial of GH001 in Patients With Treatment-resistant Depression

This double-blind, placebo-controlled trial (n=80) investigates the safety and efficacy of GH001, containing mebufotenin (5-MeO-DMT), in treating treatment-resistant depression (TRD). The study comprises a 7-day double-blind part (Part 1) and a 6-month open-label extension (OLE) part (Part 2).

Patients are randomised to receive GH001 or placebo in a 1:1 ratio. GH001 is administered in an individualized dosing regimen (IDR) with up to 3 increasing doses (6 mg, 12 mg, and 18 mg) on a single day. The primary endpoint is the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 7. Efficacy and safety assessments include depression, anxiety, and quality of life measures. GH001 is administered via inhalation, and the study, conducted by GH Research Ireland Limited, started in May 2023 and is expected to complete in December 2024.

Topic Treatment-Resistant Depression Depression
Compound 5-MeO-DMT
Country Czech Republic Germany Ireland Poland Spain
Visit trial
Status Recruiting
Results Published No
Start date 24 May 2023
End date 01 December 2024
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 80
Sex All
Age 18- 63
Therapy No

Trial Details

The aim of this randomized, double-blind, placebo-controlled, phase 2b clinical trial is to investigate the safety and efficacy of GH001 (containing mebufotenin [5-methoxy-N,N-dimethyltryptamine; 5-MeO-DMT]) in patients with treatment-resistant depression (TRD). The study is comprised of a 7-day double-blind (DB) part (Part 1) and a 6-month open-label extension (OLE) part (Part 2). Patients will be randomized to receive GH001 or placebo in a 1:1 ratio. The primary endpoint is the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 7.

NCT Number NCT05800860

Sponsors & Collaborators

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

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.