Clinical Trials Register

Summary
EudraCT Number:	2021-006879-42
Sponsor's Protocol Code Number:	GH001-PPD-203
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-03-26
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2021-006879-42

A.3

Full title of the trial

A phase 2 clinical trial of GH001 in patients with postpartum depression

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A phase 2 clinical trial of GH001 in patients with postpartum depression

A.4.1

Sponsor's protocol code number

GH001-PPD-203

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GH Research Ireland Limited
B.1.3.4	Country	Ireland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GH Research Ireland Limited
B.4.2	Country	Ireland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GH Research Ireland Limited
B.5.2	Functional name of contact point	GH Research Project Manager
B.5.3	Address:
B.5.3.1	Street Address	28 Baggot Street Lower
B.5.3.2	Town/ city	Dublin 2
B.5.3.3	Post code	D02 NX43
B.5.3.4	Country	Ireland
B.5.4	Telephone number	00355314378443
B.5.6	E-mail	clinicaltrials@ghres.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	5-MeO-DMT 6, 12, 18mg, powder in vial for reconstitution
D.3.2	Product code	GH001
D.3.4	Pharmaceutical form	Inhalation vapour, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	5-Methoxy-N,N-Dimethyltryptamine
D.3.9.1	CAS number	1019-45-0
D.3.9.2	Current sponsor code	GH001
D.3.9.3	Other descriptive name	5-methoxy-N,N-dimethyltryptamine
D.3.9.4	EV Substance Code	SUB222872
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	36
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Post-Partum Depression

E.1.1.1

Medical condition in easily understood language

Depression associated with pregnancy and childbirth

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10056393
E.1.2	Term	Postpartum depression
E.1.2	System Organ Class	100000004873

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the onset and 7-day durability of anti-depressive effects of a single-day individualized dosing regimen of 6 mg, 12 mg and 18 mg of GH001 in adult, female patients with postpartum depression (PPD).

E.2.2

Secondary objectives of the trial

• To determine:
o the anti-depressive effects;
o the anti-anxiety effects;
o the safety and tolerability;
o the intensity and duration of psychoactive effects PsE;
o the impact on cognitive outcomes.
of a single-day individualized dosing regimen of 6 mg, 12 mg and 18 mg of GH001 in adult, female patients with PPD.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Is female and in the age range between 18 and 45 years (inclusive) at screening;
• Meets the trial criteria for PPD:
• Diagnosis of Major Depressive Disorder without psychotic features, confirmed by the Mini-International Neuropsychiatric Interview (MINI) (v7.0.2), with peri-partum onset that began no earlier than gestation and no later than the first 4 weeks postpartum, and is > 4 weeks postpartum at dosing but ≤9 months postpartum at screening;
• Has a Montgomery–Åsberg Depression Rating Scale (MADRS) total score of equal to or greater than 28 at screening and pre-dose on Day 0;
• Has a Young Mania Rating Scale (YMRS) total score less than or equal to 8 at screening and pre dose on Day 0;
• Patients of child-bearing potential must agree to remain completely abstinent or use a highly effective , medically accepted contraceptive method for 30 days prior to dosing and for 30 days after GH001 dosing. Patients must have a negative pregnancy test at screening and on the pre-test day (Day -1);
• Is willing to delay start of other antidepressant or anxiety medication until after the end of the trial at Day 7 and agrees to keep any psychotherapy unchanged during the trial;
• Is willing and able to nominate a trusted caregiver that has shared legal and physical custody of the infant(s) with the patient, is living in the same household and that is available to take full responsibility for the care and attention of their infant(s) for the entirety of the test day (Day 0) and for 7 days post last dose, and that is present at screening, provides contact details and consents to being contacted by study staff during the duration of the study.

E.4

Principal exclusion criteria

• Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar disorder, a manic or hypomanic episode, a psychotic disorder, major depressive disorder (MDD) or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality disorder, clinically significant intellectual disability, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator’s judgment;
•.Has one or more first or second degree relatives with a current or previously diagnosed bipolar disorder, psychotic disorder or MDD or other mood disorder 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 clinically significant pre-menstrual syndrome or premenstrual dysphoric disorder that renders the patient unsuitable for the study according to the investigator’s judgment;
• Is in the judgment of a trial psychiatrist or registered psychologist, at significant risk for suicide based on history, psychiatric assessment, and evaluation of suicidal ideation and suicidal behaviour based on the Columbia-Suicide Severity Rating Scale (C-SSRS);
• Has had an inadequate response to an adequate course of electroconvulsive therapy, vagal nerve stimulation, repetitive transcranial magnetic or electrical stimulation, or deep brain stimulation in the current episode of depression as assessed using the ATHF-SF;
• Has abnormal thyroid function at screening;
• Patient who has a positive pregnancy test at screening or on the pre-test day (Day -1), is pregnant, or plans to become pregnant during the course of the trial and up to 30 days after GH001 dosing.
• Patients with DSM-5 drug or alcohol use disorder within 6 months prior to screening;

E.5 End points

E.5.1

Primary end point(s)

• The anti-depressive effects of GH001 evaluated by:
o Change from baseline in MADRS

E.5.1.1

Timepoint(s) of evaluation of this end point

• Prior to first dose on Day 0 (Baseline),
• Day 7

E.5.2

Secondary end point(s)

The anti-depressive effects of GH001 evaluated by:
• The proportion of patients in remission (MADRS≤10);
• Change from baseline in MADRS ;
• The proportion of responders (≥50% reduction from baseline in MADRS total score);
• Change from baseline in Clinical Global Impression – Severity scale (CGI-S) ;
• The anti-anxiety effects of GH001 evaluated by change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) total score;
• Exposure of 5-MeO-DMT and bufotenine in blood;
The safety and tolerability of GH001 evaluated by:
• Reporting of Treatment Emergent Adverse Events (TEAEs);
• Clinically significant changes from baseline in ECG, vital signs, safety laboratory assessments and peak flow respirometry;
• Assessment of sedation (Modified Observer's Assessment of Alertness and Sedation scale [MOAA/S]);
• Change from baseline in Clinician Administered Dissociative States Scale (CADSS);
• Assessment of patient discharge readiness using the Clinical Global Assessment of Discharge Readiness (CGADR);
• Change from baseline in Brief Psychiatric Rating Scale (BPRS);
• Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS);
• Change from baseline in Young Mania Rating Scale (YMRS);
The PsE experienced by the patients when the PsE has subsided:
• PsE assessment using the Peak Experience (PE) scale to assess the achievement of a PE (PE scale total score ≥75);
• Challenging Experience Questionnaire (CEQ);
• Mystical Experience Questionnaire (MEQ-30);
• Duration of the PsE defined as the time from study drug dosing to the time when the PsE have subsided;
The impact on cognitive outcomes as evaluated by:
• Psychomotor Vigilance Task;
• Auditory Verbal Learning Test;
• Spatial Working Memory Task;
• Digit Symbol Substitution Task.

E.5.2.1

Timepoint(s) of evaluation of this end point

• 2 hours after the final study drug dosing on Day 0, and at Day 1 and Day 7;
• 2 hours after the final study drug dosing on Day 0, and at Day 1;
• 2 hours after the final study drug dosing on Day 0, and at Day 1 and Day 7;
• Day 0, and at Day 1 and Day 7;
• Day 0, Day 1 and Day 7;
• Day -1 and Day 0, Day 1, Day 7;
• from first dosing to Day 7;
• Day-1, Day 0, Day 1 and Day 7;
• Day 0;
• Day 0 and at Day 1 and Day 7;
• Day 0;
• Day-1, Day 0, Day 1 and Day 7;
• Day 0, Day 1 and Day 7;
• immediately after each dosing;
• Day 0;
• Day 0;
• Day 0;
• Day-1, Day 0, Day 7;
• Day-1, Day 0, Day 7;
• Day-1, Day 0, Day 7;
• Day-1, Day 0, Day 7;

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Open-label, non-randomized, single arm

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

United Kingdom

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Lactating and non-lactating female patients > 4 weeks to ≤9 months postpartum

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-03-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-08-30

P. End of Trial
P.	End of Trial Status	Ongoing

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