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TerminatedPhase 2

Phase 2 Clinical Trial of GH001 in Postpartum Depression

NCT05804708 · GH Research Ireland Limited

Closed to entry
Status
Not accepting participants
Phase 2
Phase
10
Target enrolment
4
Study sites
Outside the US

What it is testing

Summary

This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 female participants with clinically diagnosed postpartum depression (PPD) will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7

    Measured over From Baseline to Day 7

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
FEMALE
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Is female and in the age range between 18 and 45 years (inclusive) at screening. * Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at screening. * Meets the trial criteria for PPD as assessed by a trial psychiatrist or registered clinical psychologist. Exclusion Criteria: * Has one or more first or second degree relatives with a current or prior diagnosis of bipolar disorder, psychotic disorder or other mood disorder (including MDD) with psychotic features. * Current pregnancy resulting in termination, still-birth, pre-term delivery (before week complete gestational week 37), need for intensive care therapy of mother or child, or adoption of child away from patient. * Has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing. * Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator's judgment. * Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters which renders the patient unsuitable for the trial according to the investigator's judgment. * Patient who has a positive pregnancy test at screening or on the pretest day, is pregnant, or plans to become pregnant during the course of the trial and up to 90 days after GH001 dosing.

Where

4 study sites

FacilityCityRegionCountry
Amsterdam UMCAmsterdamNetherlands
Clerkenwell HealthLondonUnited Kingdom
St. Pancras Clinical ResearchLondonUnited Kingdom
Sheffield Health and Social Care NHS FoundationSheffieldUnited Kingdom

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05804708 on ClinicalTrials.gov →

Last updated in the registry 2025-02-18. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits