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