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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05804708
Other study ID # GH001-PPD-203
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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