Phase 2 Clinical Trial of GH001 in Postpartum Depression

GH Research

Status and phase: Terminated; Phase 2

Conditions: Postpartum Depression; Postnatal Depression

Treatments: Drug: GH001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05804708

GH001-PPD-203

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

GH001 Individualized Dosing Regimen

Experimental group

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

Treatment:

Drug: GH001