Clinical trial

A Trial of GH001 in Patients With Treatment-resistant Depression

GH Research Ireland LimitedCompletedPhase 2Started May 24, 202381 enrolledCzechia, Germany, Ireland, Netherlands, Poland, SpainNCT05800860

Abstract

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.

Topics & conditions

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DMTDepression

Keywords

Treatment-resistant depressionMajor depressive disorderGH0015-MeO-DMT5-methoxy-N,N-dimethyltryptamineMebufoteninTreatment-resistant Depression

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