Phase 2 Clinical Trial of GH001 in Postpartum Depression

Last updated: February 14, 2025
Sponsor: GH Research Ireland Limited
Overall Status: Terminated

Phase

2

Condition

Depression (Major/severe)

Post-partum Depression

Depression

Treatment

GH001

Clinical Study ID

NCT05804708
GH001-PPD-203
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

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) atscreening.

  • Meets the trial criteria for PPD as assessed by a trial psychiatrist or registeredclinical psychologist.

Exclusion

Exclusion Criteria:

  • Has one or more first or second degree relatives with a current or prior diagnosisof bipolar disorder, psychotic disorder or other mood disorder (including MDD) withpsychotic features.

  • Current pregnancy resulting in termination, still-birth, pre-term delivery (beforeweek complete gestational week 37), need for intensive care therapy of mother orchild, or adoption of child away from patient.

  • Has taken prohibited medication or prohibited dietary supplements within thespecified timeframe prior to dosing.

  • Has previously experienced a significant adverse reaction to a hallucinogenic orpsychedelic 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 trialaccording to the investigator's judgment.

  • Patient who has a positive pregnancy test at screening or on the pretest day, ispregnant, or plans to become pregnant during the course of the trial and up to 90days after GH001 dosing.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: GH001
Phase: 2
Study Start date:
March 02, 2023
Estimated Completion Date:
November 15, 2024

Connect with a study center

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Site Not Available

  • QPS Netherlands

    Groningen,
    Netherlands

    Site Not Available

  • Clerkenwell Health

    London,
    United Kingdom

    Site Not Available

  • St. Pancras Clinical Research

    London,
    United Kingdom

    Site Not Available

  • Sheffield Health and Social Care NHS Foundation

    Sheffield,
    United Kingdom

    Site Not Available

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