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
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Sponsors & Collaborators

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

Data attribution

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