International Journal of Neuropsychopharmacology
September 1, 2026
W. Cubała, K. Doolin, F. Ryan et al.
Abstract Background Treatment-resistant depression (TRD) represents a particularly challenging form of major depressive disorder (MDD), defined by an inadequate response to at least two antidepressants given at adequate dose and duration within the current depressive episode. TRD affects nearly one-third of individuals with MDD and is consistently linked to greater psychiatric and medical...
International Journal of Neuropsychopharmacology
September 1, 2026
B. T. Baune, T. Benway, D. Gregory et al.
Abstract Background Treatment-resistant depression (TRD) is a chronic condition affecting approximately 30% of patients with major depressive disorder, posing a significant unmet need for safe and effective treatments. GH001, an inhaled formulation of mebufotenin (5-MeO-DMT), has shown good tolerability and safety in early stage clinical trials in healthy volunteers and patients with TRD. Aims...
Psychopharmacology Bulletin
June 5, 2026
Michael E. Thase, Brian Brennan, Rachael Macisaac et al.
Approximately 30% of patients treated for major depressive disorder develop treatment-resistant depression (TRD). The STAR*D study demonstrated remission rates decline progressively with each antidepressant failure (37%, 31%, 14%, and 13%, respectively). A single-day individualized dosing regimen of GH001 (synthetic mebufotenin for inhalation) produced rapid, large improvements in depressive...
The Journal of Clinical Psychiatry
June 3, 2026
Martin Johnson, Pau Aceves Baldo, Emilio Arbe et al.
Objective: Postpartum depression (PPD) is a debilitating mood disorder with peripartum onset. Current treatment options are limited in PPD. GH001 is a synthetic inhalation formulation of the psychoactive molecule mebufotenin (5-MeO-DMT). This trial investigated the preliminary efficacy and safety of GH001 in adult females with PPD. Methods: This phase 2a, proof-of-concept, open-label trial...
European Psychiatry
June 1, 2026
Eduard Vieta, Bernhard T Baune, N. Cardoner et al.
Introduction 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...
JAMA Psychiatry
March 25, 2026
Wiesław Jerzy Cubała, Malek Bajbouj, Michael Bauer et al.
3 citations
Importance: Few pharmacotherapies are approved for treatment-resistant depression, and many patients do not achieve remission following treatment with those therapies. Objective: To examine the efficacy and safety of single-day treatment with a synthetic formulation of inhaled mebufotenin (GH001) vs placebo in patients with treatment-resistant depression. Design, Setting, and Participants: This...