Phase 2 Clinical Trial of GH001 in Postpartum Depression

Postpartum Depression Clinical Trial

Official title:

A Phase 2 Clinical Trial of GH001 in Patients With Postpartum Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804708
• Other study ID #: GH001-PPD-203
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2, 2023
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: GH Research Ireland Limited
• Contact: Project Manager
• Phone: + 353 1 437 8334
• Email: clinicaltrials[@]ghres.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression
• Postpartum Depression

Intervention

Drug:
• GH001
GH001 is administered via inhalation

Locations

Country	Name	City	State
Netherlands	QPS Netherlands	Groningen
United Kingdom	St. Pancras Clinical Research	London

Sponsors (1)

Lead Sponsor	Collaborator
GH Research Ireland Limited

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7	The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item is scored from 0 to 6. The overall score ranges from 0 to 60	From Baseline to Day 7