A Trial of GH001 in Patients With Treatment-resistant Depression

This Phase 2b trial randomises patients with treatment‑resistant depression 1:1 to a single‑day individualized inhalation dosing regimen (IDR) of GH001 (5‑MeO‑DMT; up to 3 escalating doses: 6, 12, 18 mg) or placebo in a double‑blind parallel design; primary endpoint is change in MADRS at Day 7.

Patients completing the 7‑day double‑blind part may enter a 6‑month open‑label extension during which they may receive up to five GH001 IDRs as clinically indicated; safety, mood, anxiety and quality‑of‑life measures are assessed across both parts.