GH001 vs Placebo in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial - PubMed

5 hours ago

GH001, a synthetic formulation of inhaled mebufotenin, was tested against placebo in a randomized clinical trial for treatment-resistant depression.
The study was a 7-day, double-blind, placebo-controlled phase 2b trial with an open-label extension phase, conducted at 16 sites in Europe.
81 patients aged 18-64 with treatment-resistant depression were randomized to receive GH001 (n=40) or placebo (n=41).
GH001 showed significant improvement in Montgomery-Åsberg Depression Rating Scale scores compared to placebo (mean difference: -15.5, P < .001).
57.5% of GH001-treated patients achieved remission (Montgomery-Åsberg score ≤10) by day 8, compared to 0% in the placebo group.
No severe or serious adverse events were reported during the placebo-controlled period.
The study supports GH001 as a potential rapid-acting treatment for treatment-resistant depression.

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