Clinical TrialPostpartum Depression5-MeO-DMTTerminated

Phase 2 Clinical Trial of GH001 in Postpartum Depression

This is a single-arm, open-label Phase II clinical trial (n=15) investigating the anti-depressive effects of GH001 in postpartum depression (PPD) patients.

Target Enrollment
10 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Multicentre, open-label, single-group Phase 2 study of inhaled GH001 (5-MeO-DMT) in female participants with postpartum depression; individualised dosing (up to three inhaled doses in one day).

Up to three escalating inhaled doses (6, 12, 18 mg) are given within a single day; subsequent doses are administered only if a peak experience (PE) is not achieved at the prior dose.

Key eligibility: females 18–45 years, BMI 18.5–35 kg/m2, diagnosis of PPD; exclusions include family history of bipolar/psychotic disorders and pregnancy.

Planned/actual enrolment from registry indicates 10 participants to date; study sites include Amsterdam UMC and multiple UK clinical research centres.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

GH001 IDR

experimental

Individualised inhaled dosing regimen of GH001 (5-MeO-DMT) with up to three escalating inhaled doses on a single day.

Interventions

  • 5-MeO-DMT6 - 18 mg
    via Inhalation• single day• 3 doses total

    IDR up to 3 inhaled doses (6, 12, 18 mg); subsequent doses given only if no peak experience (PE) at prior dose.

Participants

Ages
18 – 45
Sexes
female

Inclusion Criteria

  • 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

  • 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.

Study Details

  • Status
    Terminated
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2023-03-02
    End: 2023-12-01
  • Compound
    5-MeO-DMT
  • Topic
    Postpartum Depression

Locations

Amsterdam UMC — Amsterdam, Netherlands
Clerkenwell Health — London, United Kingdom
St. Pancras Clinical Research — London, United Kingdom
Sheffield Health and Social Care NHS Foundation — Sheffield, United Kingdom

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