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...
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...
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...