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. Commenced on March 2, 2023, and scheduled for completion in December 2023, this study is conducted across multiple centres in the Netherlands and the UK.

Female participants aged 18 to 45 years, with a BMI between 18.5 and 35 kg/m², diagnosed with PPD, are included. GH001, administered via inhalation in individualized dosing regimens (6 mg, 12 mg, and 18 mg), is evaluated for its impact on depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) over the course of seven days.

The trial is designed as an interventional, single-group assignment with no masking. Researchers are reachable through [email protected], and enrolment is set to include 15 participants. Eligibility criteria involve factors such as age, BMI, and the presence of PPD, while exclusion criteria consider factors like familial psychiatric history and prohibited medications. The primary outcome measure is the change from baseline in MADRS at Day 7. The sponsor is GH Research Ireland Limited, and the study contributes to the understanding of GH001’s efficacy in treating PPD. The study registration started on March 27, 2023, and the first posting on ClinicalTrials.gov was on April 7, 2023.

Topic Postpartum Depression Depression
Compound 5-MeO-DMT
Country Netherlands United Kingdom
Visit trial
Status Recruiting
Results Published No
Start date 02 March 2023
End date 01 December 2023
Phase Phase II
Design Open
Type Interventional
Generation Second
Participants 15
Sex Female
Age 18- 45
Therapy No

Trial Details

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.

NCT Number NCT05804708

Sponsors & Collaborators

GH Research
GH Research is developing several 5-MeO-DMT based therapeutic mechanisms for various mental health disorders.

Data attribution

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