Phase 2 Clinical Trial of GH001 in Postpartum Depression
Key facts
- Who runs it
- GH Research Ireland Limited
- Where
- Netherlands and United Kingdom4 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 10 people enrolled
- Started
- 2 Mar 2023
- Ended
- 15 Nov 2024
- Type of study
- Interventional
- Treatments tested
- GH001
- Record updated
- 18 February 2025
- Why it stopped
- Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population.
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- GH001 Individualized Dosing RegimenTreatment being tested
Drug: 5-Methoxy-N,N-Dimethyltryptamine GH001 is administered via inhalation, as an IDR (individualized dosing regimen) consisting of up to 3 increasing doses of GH001 (6 mg, 12 mg, and 18 mg), on a single day. The second and third doses are only administered if the patient did not achieve intense psychoactive effects (a peak experience \[PE\]) at the previously administered dose
Treatment: GH001
Results explained
A paper that names this trial, explained in plain words.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 2 Clinical Trial of GH001 in Patients with Postpartum Depression
- Publications
- Inhaled Mebufotenin (GH001) for Adult Patients With Postpartum Depression: A Phase 2a Open-Label Clinical Trial.The Journal of clinical psychiatry, 2026
- Record updated
- 18 February 2025