Phase 2 Clinical Trial of GH001 in Postpartum Depression

NCT ID: NCT05804708

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2024-11-15

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.

Conditions

Postpartum Depression; Postnatal Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GH001 Individualized Dosing Regimen

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

Group Type: EXPERIMENTAL

GH001

Intervention Type: DRUG

GH001 is administered via inhalation

Interventions

GH001

GH001 is administered via inhalation

Intervention Type: DRUG

Other Intervention Names

5-Methoxy-N,N-Dimethyltryptamine; 5-MeO-DMT; Mebufotenin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GH Research Ireland Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Amsterdam UMC

Amsterdam, , Netherlands

Clerkenwell Health

London, , United Kingdom

St. Pancras Clinical Research

London, , United Kingdom

Sheffield Health and Social Care NHS Foundation

Sheffield, , United Kingdom

Countries

Netherlands; United Kingdom

Other Identifiers

GH001-PPD-203

Identifier Type: -

Identifier Source: org_study_id