A Trial of GH001 in Patients With Treatment-resistant Depression
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
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.