Phase 2 Clinical Trial of GH001 in Postpartum Depression

NCT05804708 | Terminated Phase 2

• 1 other identifier: GH001-PPD-203
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 4

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

Keywords

Depression; Postpartum Depression; 5-Methoxy-N,N-Dimethyltryptamine; 5-MeO-DMT; Mebufotenin; Postnatal Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GH001 Individualized Dosing Regimen

EXPERIMENTAL

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

Drug: GH001

Interventions

GH001 DRUG

GH001 is administered via inhalation

Also known as: 5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, Mebufotenin

GH001 Individualized Dosing Regimen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GH Research Ireland Limited: lead

Study Sites (4)

Amsterdam UMC

Amsterdam, Netherlands

Location

Clerkenwell Health

London, United Kingdom

Location

St. Pancras Clinical Research

London, United Kingdom

Location

Sheffield Health and Social Care NHS Foundation

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Depression, Postpartum; Depression

Interventions

Methoxydimethyltryptamines

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

N,N-Dimethyltryptamine; Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Bufotenin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Serotonin

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: March 2, 2023
• Primary Completion: August 2, 2024
• Study Completion: November 15, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); NL (1)