{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T21:19:07Z","timestamp":1793395147160,"version":"4.5.0"},"reference-count":38,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Psychiatry"],"published-print":{"date-parts":[[2026,6,1]]},"abstract":"\n Importance<\/jats:title>\n Few pharmacotherapies are approved for treatment-resistant depression, and many patients do not achieve remission following treatment with those therapies.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This was a 7-day, randomized, double-blind, placebo-controlled phase 2b trial with a 6-month open-label extension phase conducted at 16 sites in Europe from May 2023 to March 2025. Adult patients aged 18 to 64 years with treatment-resistant depression, defined as nonresponse to 2 to 5 oral antidepressant treatments, with current episode duration of up to 2 years were included. Of 128 assessed for eligibility, 81 were randomized and completed the placebo-controlled period of the trial.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Patients were randomly assigned 1:1 to receive an individualized dosing regimen of up to 3 escalating doses of GH001 (6, 12, and 18 mg) or a placebo individualized dosing regimen on a single day (day 1).<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary efficacy end point was the change from baseline to day 8 in Montgomery-\u00c5sberg Depression Rating Scale total score (range, 0-60; higher scores indicate greater severity of depression), comparing GH001 with placebo. Secondary end points included remission (Montgomery-\u00c5sberg Depression Rating Scale score \u226410) at day 8.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Among the 81 patients randomized to GH001 (n\u2009=\u200940) or placebo (n\u2009=\u200941), the mean (SD) age was 41.6 (11.4) years and 43.9 (10.9) years and 24 (60.0%) and 22 (53.7%) were female, respectively. Change in Montgomery-\u00c5sberg Depression Rating Scale score from baseline to day 8 was significantly greater for GH001 vs placebo (least squares mean difference [SE], \u221215.5 [1.7];\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001; effect size, \u22122.0). Day 8 remission rates were 23\/40 (57.5%) with GH001 and 0\/41 (0%) with placebo. No severe or serious adverse events were reported in the placebo-controlled period.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this study, an individualized dosing regimen of inhaled GH001 resulted in significant improvements in depression symptoms relative to placebo and was well tolerated, supporting its potential as a novel, rapid-acting treatment for treatment-resistant depression.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05800860<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamapsychiatry.2026.0096","type":"journal-article","created":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T15:30:45Z","timestamp":1774452645000},"page":"561","source":"Crossref","is-referenced-by-count":18,"title":["GH001 vs Placebo in Patients With Treatment-Resistant Depression"],"prefix":"10.1001","volume":"83","author":[{"given":"Wies\u0142aw 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