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Clinical Study of GH001 in Depression

CompletedRegisteredCTG

The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of depressive symptoms, and its dose-related psychoactive effects in patients with Treatment-Resistant Depression (TRD).

Details

Phase 1/2, open-label, non-randomised, sequential study in patients with treatment-resistant depression testing inhaled GH001 (5‑MeO‑DMT) in two single-dose levels (Part A) and an individualized dosing regimen (Part B).

Primary objectives: safety/tolerability of single doses (Part A) and effect of individualized dosing on depressive symptom severity (Part B). Outcomes include safety measures and depression rating scales across acute and follow-up assessments.

Topics:Treatment-Resistant Depression (TRD)

Registry

Registry linkNCT04698603