Long term efficacy and safety of GH001 in patients with treatment-resistant depression
Eduard Vieta, Bernhard T Baune, N. Cardoner, RM Dueñas Herrero, Luboš Janů, J.R. Kelly, Shane Mcinerney, Alexander Nawka, Tomáš Páleníček, Víctor Pérez Sola, Andreas Reif, Michael E. Thase, Velichka Valcheva, Wiesław Jerzy Cubała
European Psychiatry June 1, 2026 DOI: 10.1192/j.eurpsy.2026.10582 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Double-blind Peer reviewed |
|---|---|
| Population | Patients with treatment-resistant depression |
| Duration | 6-month follow-up |
| Topics | Depression |
| Keywords | Depression economics Placebo Adverse effect Dosing Regimen Depressive symptoms Randomized controlled trial Rating scale Clinical trial |
| Key findings | The text reports the rationale and design of a Phase 2b randomized, double-blind trial testing GH001, an inhalable synthetic mebufotenin formulation, for treatment-resistant depression with a 6-month follow-up. It states that preliminary clinical trials indicate GH001 may rapidly improve depressive symptoms in this population, but no results from the present trial are given. |
Abstract
Treatment-resistant depression (TRD), a persistent condition impacting up to 30% of patients with major depressive disorder, carries substantial personal and economic burden. There remains an unmet need for therapies that provide both rapid and durable improvements in TRD. Preliminary clinical trials indicate that GH001, a synthetic, inhalable formulation of mebufotenin, has the potential for rapid improvement of depressive symptoms in this population. Objectives This trial investigated the efficacy and safety of GH001 in patients with TRD in a Phase 2b randomized double-blind trial with a 6-month follow-up.
Comparable studies
Other randomized controlled trials on depression, most cited first.