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This phase 2b randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of GH001, an investigational inhaled formulation of mebufotenin, in adults with treatment-resistant depression who had not responded to two to five oral antidepressant treatments. Eighty-one participants were randomized to receive a single-day individualized dosing regimen of GH001 (n = 40) or placebo (n = 41), with doses of 6, 12, and 18 mg administered sequentially when indicated. At day 8, the reduction in Montgomery–Åsberg Depression Rating Scale (MADRS) scores was significantly greater with GH001 than with placebo, with a least-squares mean difference of −15.5 points (standard error, 1.7; P < 0.001; Cohen’s d = −2.0). Remission was achieved by 23/40 participants (57.5%) receiving GH001 compared with 0/41 receiving placebo; response rates were 60.0% and 0%, respectively. No severe or serious adverse events were reported during the placebo-controlled phase, although the trial was small and the characteristic psychoactive effects could have compromised blinding. In the six-month open-label extension, most participants who initially achieved remission required further treatment to maintain improvement. Conclusion: GH001 showed a substantial, rapid antidepressant effect in this phase 2b trial, but larger confirmatory studies are required to establish its longer-term efficacy, safety, and clinical role.
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This phase 2b randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of GH001, an investigational inhaled formulation of mebufotenin, in adults with treatment-resistant depression who had not responded to two to five oral antidepressant treatments. Eighty-one participants were randomized to receive a single-day individualized dosing regimen of GH001 (n = 40) or placebo (n = 41), with doses of 6, 12, and 18 mg administered sequentially when indicated. At day 8, the reduction in Montgomery–Åsberg Depression Rating Scale (MADRS) scores was significantly greater with GH001 than with placebo, with a least-squares mean difference of −15.5 points (standard error, 1.7; P < 0.001; Cohen’s d = −2.0). Remission was achieved by 23/40 participants (57.5%) receiving GH001 compared with 0/41 receiving placebo; response rates were 60.0% and 0%, respectively. No severe or serious adverse events were reported during the placebo-controlled phase, although the trial was small and the characteristic psychoactive effects could have compromised blinding. In the six-month open-label extension, most participants who initially achieved remission required further treatment to maintain improvement. Conclusion: GH001 showed a substantial, rapid antidepressant effect in this phase 2b trial, but larger confirmatory studies are required to establish its longer-term efficacy, safety, and clinical role.
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