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Phase 2 Clinical Trial of GH001 in Postpartum Depression

Primary Purpose

Postpartum Depression

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GH001
Sponsored by
GH Research Ireland Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring Depression, Postpartum Depression, 5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, Mebufotenin

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • QPS NetherlandsRecruiting
  • St. Pancras Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GH001 Individualized Dosing Regimen

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 27, 2023
Last Updated
May 2, 2023
Sponsor
GH Research Ireland Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05804708
Brief Title
Phase 2 Clinical Trial of GH001 in Postpartum Depression
Official Title
A Phase 2 Clinical Trial of GH001 in Patients With Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GH Research Ireland Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Depression, Postpartum Depression, 5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, Mebufotenin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GH001 Individualized Dosing Regimen
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
GH001
Other Intervention Name(s)
5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, Mebufotenin
Intervention Description
GH001 is administered via inhalation
Primary Outcome Measure Information:
Title
The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7
Description
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
Time Frame
From Baseline to Day 7

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Project Manager
Phone
+ 353 1 437 8334
Email
clinicaltrials@ghres.com
Facility Information:
Facility Name
QPS Netherlands
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
St. Pancras Clinical Research
City
London
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 2 Clinical Trial of GH001 in Postpartum Depression

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