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GH001 vs Placebo in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial
Wieslaw J Cubala1, Malek Bajbouj2, Michael Bauer3
1Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland.
JAMA Psychiatry
|March 25, 2026
Summary
Inhaled mebufotenin (GH001) significantly improved treatment-resistant depression symptoms in a single day compared to placebo. This novel therapy showed rapid action and was well-tolerated, offering new hope for patients.
Area of Science:
- Psychiatry
- Pharmacology
- Clinical Trials
Background:
- Treatment-resistant depression (TRD) has limited pharmacotherapy options.
- Many patients do not achieve remission with existing treatments for TRD.
Purpose of the Study:
- To evaluate the efficacy and safety of inhaled mebufotenin (GH001) versus placebo for TRD.
- To assess GH001's potential as a rapid-acting treatment for TRD.
Main Methods:
- A 7-day, randomized, double-blind, placebo-controlled phase 2b trial.
- 81 adult patients with TRD received individualized dosing of GH001 or placebo on day 1.
- Efficacy measured by change in Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to day 8.
Main Results:
- GH001 significantly reduced MADRS scores compared to placebo (mean difference -15.5, P < .001).
- Remission rates at day 8 were 57.5% for GH001 versus 0% for placebo.
- No severe or serious adverse events were reported during the placebo-controlled period.
Conclusions:
- Inhaled GH001 demonstrated significant efficacy in improving depression symptoms in TRD patients.
- GH001 was well-tolerated and showed potential as a novel, rapid-acting treatment for TRD.
- Further research may support GH001 as a new therapeutic option for TRD.
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