At a glance
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A Randomized, Double-blind, Placebo-controlled, Phase 2b Trial With an Open-label Extension to Determine the Safety and Efficacy of GH001 in Patients With Treatment-resistant Depression
In Brief
A Phase 2 clinical trial evaluating GH001 and Placebo for Treatment-resistant Depression. Completed, enrolled 81 participants across 11 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
GH001 administered via inhalation
Placebo administered via inhalation