Phase 2 Clinical Trial of GH001 in Postpartum Depression

Study Overview
=================
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.

Official Title
-----------------
A Phase 2 Clinical Trial of GH001 in Patients With Postpartum Depression

Conditions
-----------------
Postpartum Depression, Postnatal Depression

Intervention / Treatment
-----------------
* Drug: GH001


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GH001 Individualized Dosing Regimen<br>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<br>* GH001 is administered via inhalation<br>* Other names: Mebufotenin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Postpartum Depression, 5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, Mebufotenin, Postnatal Depression