Company: GHRS
Filing Date: 2025-02-27
Form Type: 20-F
Source: 0001140361-25-006175
Chunk: 25

Company: GH Research PLC
Filing Date: 2025-02-27
Form: 20-F
Item: Item 4
Chunk 25
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 a component of either part of this trial. All patients in the trial (i) had moderate to severe depression, (ii) had experienced a recurrent or single MDD episode (per DSM-5 criteria) without psychotic features, with a current episode of at least 2 years, (iii) had failed between 2 and 5 antidepressants prior to enrollment and (iv) had taken antidepressant treatments at least at the minimum applicable dose for at least 6 weeks.
 
In both parts, GH001 is administered as an IDR consisting of up to 3 increasing doses of GH001 (6 mg, 12 mg, and 18 mg) given at a planned 1-hour interval.
 

•   In the double-blind Part 1, patients received either a single GH001 IDR or placebo IDR.
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•   In the OLE Part 2, patients can receive up to 5 GH001 IDRs as needed across 6 months, based on specific re-treatment criteria. Re-treatment criteria include the severity of depression and the effectiveness, tolerability and
                                                                                                        number of previous IDRs.                                                                                                   
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Patients of 18 to 64 years of age (inclusive) were eligible to be enrolled in the trial, with GH001 to be administered without additional mandated visits for psychological intervention.
 
The primary endpoint is to assess the effects on the severity of depression, as assessed by the mean change in MADRS from baseline to Day 8 at the end of the double-blind phase. The MADRS is a widely accepted scale for depression that ranges from zero to 60 that has been used as a primary endpoint in pivotal trials of other depression treatments. The FDA draft guidance for industry “Major Depressive Disorder: Developing Drugs for Treatment” highlights that for rapid-acting anti-depressants, efficacy generally should be demonstrated within 1 week for a rapid-acting antidepressant.
 

<{self.tag} alt="{self.alt}" src="{self.src}">  Table of Contents
 

  Table of Contents
<{self.tag} alt="{self.alt}" src="{self.src}">Results: Patient Disposition and Characteristics
 
 
1 For patients in the GH001/placebo groups, up to 3 doses of GH001 or placebo were administered;
 2 Includes all patients who received respective dose of GH001/placebo, irrespective of total dose
 Abbreviations: BMI = Body mass index; HAM-D-17 = Hamilton Rating Scale for Depression; MADRS = Montgomery-Å