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Clinical Study of GH001 in Depression

Primary Purpose

Treatment Resistant Depression, Major Depressive Disorder, Depression

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
5 Methoxy N,N Dimethyltryptamine
Sponsored by
GH Research Ireland Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Treatment, 5-MeO-DMT, 5-methoxy-dimethyltryptamine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
  • Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI);
  • Treatment-Resistant Depression as evaluated by the Antidepressant Treatment History Form - Short Form (ATHF-SF);
  • Has outpatient status at screening and enrolment visits;

Exclusion Criteria:

  • Has a current or prior diagnosis of a psychiatric comorbidity that renders the patient unsuitable for the study according to a study psychiatrist or registered psychologist;
  • Has received any investigational medication within the last 1 month;
  • Has a current medically significant condition (e.g., severe infection) or has a history of a medically significant condition (e.g., medical history of seizure, uncontrolled hypertension, uncontrolled diabetes, severe cardiovascular disease, hepatic or renal failure, etc.) that renders the patient unsuitable for the study according to the medical supervisor's judgment;
  • Takes any medication or other substance that renders the patient unsuitable for the study according to the medical supervisor's judgment;
  • Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters, which renders the patient unsuitable for the study according to the medical supervisor's judgment;

Sites / Locations

  • Clinical Trial Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase 1 (Part A): GH001 dose A

Phase 1 (Part A): GH001 dose B

Phase 2 (Part B): GH001 Individualized Dosing Regimen

Arm Description

Outcomes

Primary Outcome Measures

Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13.
Phase 1: The primary endpoint is a binary variable (yes/no) reflecting a combined medical/clinical evaluation of the occurrence of Outcomes 5 to 13. The endpoint will be considered met for any dose level or regimen if the Study Safety Group (SSG) - through a qualitative medical/clinical evaluation - considers that dose level or regimen sufficiently safe and tolerable for potential further clinical development in a subsequent study.
Phase 2: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
Phase 2: The assessment is done with the Montgomery-Asberg Depression Rating Scale (MADRS), a diagnostic questionnaire with ten items for measuring 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.

Secondary Outcome Measures

Phase 1: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
Phase 1: The assessment is done with the Montgomery-Asberg Depression Rating Scale (MADRS), a diagnostic questionnaire with ten items for measuring 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.
Phase 2: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13
Phase 2: The secondary endpoint is a binary variable (yes/no) reflecting a combined medical/clinical evaluation of the occurrence of Outcomes 5 to 13. The endpoint will be considered met for any dose level or regimen if the Study Safety Group (SSG) - through a qualitative medical/clinical evaluation - considers that dose level or regimen sufficiently safe and tolerable for potential further clinical development in a subsequent study.

Full Information

First Posted
November 17, 2020
Last Updated
August 11, 2023
Sponsor
GH Research Ireland Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04698603
Brief Title
Clinical Study of GH001 in Depression
Official Title
A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
November 6, 2021 (Actual)
Study Completion Date
November 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GH Research Ireland Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of depressive symptoms, and its dose-related psychoactive effects in patients with Treatment-Resistant Depression (TRD). The study is comprised of two open-label, single-arm study parts where Part A evaluates single doses of GH001 at two dose levels and Part B evaluates a specific individualized dosing regimen of GH001.
Detailed Description
Phase 1 (Part A): The primary objective of this study is to assess the safety and tolerability of single doses of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT) in patients with TRD. The secondary objectives of the study are to assess the effects of single doses of GH001 on various measures of depression, and on dose-related psychoactive effects. Phase 2 (Part B): The primary objective of this study is to assess the effects of an individualized dosing regimen of GH001 on the severity of depression. The secondary objectives of the study are to assess the safety and tolerability of an individualized dosing regimen of GH001 in patients with TRD and its effects on the severity of depression, other measures of depression, and on dose-related psychoactive effects. Study design: Phase 1/2 study in two parts. Intervention: In the Phase 1 (Part A), a single dose of GH001 will be administered per patient. Two different dose levels will be investigated with four patients at each dose level. In the Phase 2 (Part B), an individualized dosing regimen will be administered. In both parts, GH001 will be administered via inhalation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Major Depressive Disorder, Depression
Keywords
Treatment, 5-MeO-DMT, 5-methoxy-dimethyltryptamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Phase 1 (Part A): Two dose levels of GH001 investigated in single doses. Phase 2 (Part B): GH001 investigated in an individualized dosing regimen.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 (Part A): GH001 dose A
Arm Type
Experimental
Arm Title
Phase 1 (Part A): GH001 dose B
Arm Type
Experimental
Arm Title
Phase 2 (Part B): GH001 Individualized Dosing Regimen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
5 Methoxy N,N Dimethyltryptamine
Other Intervention Name(s)
GH001, 5-MeO-DMT
Intervention Description
GH001 administered via inhalation
Primary Outcome Measure Information:
Title
Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13.
Description
Phase 1: The primary endpoint is a binary variable (yes/no) reflecting a combined medical/clinical evaluation of the occurrence of Outcomes 5 to 13. The endpoint will be considered met for any dose level or regimen if the Study Safety Group (SSG) - through a qualitative medical/clinical evaluation - considers that dose level or regimen sufficiently safe and tolerable for potential further clinical development in a subsequent study.
Time Frame
up to 7 days
Title
Phase 2: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
Description
Phase 2: The assessment is done with the Montgomery-Asberg Depression Rating Scale (MADRS), a diagnostic questionnaire with ten items for measuring 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.
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Phase 1: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
Description
Phase 1: The assessment is done with the Montgomery-Asberg Depression Rating Scale (MADRS), a diagnostic questionnaire with ten items for measuring 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.
Time Frame
up to 7 days
Title
Phase 2: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13
Description
Phase 2: The secondary endpoint is a binary variable (yes/no) reflecting a combined medical/clinical evaluation of the occurrence of Outcomes 5 to 13. The endpoint will be considered met for any dose level or regimen if the Study Safety Group (SSG) - through a qualitative medical/clinical evaluation - considers that dose level or regimen sufficiently safe and tolerable for potential further clinical development in a subsequent study.
Time Frame
up to 7 days
Other Pre-specified Outcome Measures:
Title
Type and Frequency of Adverse Events
Description
Adverse events reported in the study and coded by MedDRA.
Time Frame
up to 7 days
Title
Frequency of clinically significant changes from baseline in the safety laboratory analyses (biochemistry, hematology, urinalysis)
Description
Safety laboratory analyses are analyses of blood samples (biochemistry, hematology) and urine samples (urinalysis). Changes are defined as any clinically significant change from baseline as determined by the medical supervisor at the site.
Time Frame
up to 7 days
Title
Frequency of clinically significant changes from baseline in Vital Signs
Description
Vital signs include heart rate (beats per minute), blood pressure (mmHg), respiratory rate (breaths per minute), oxygen saturation (%), and temperature (degrees celsius). Changes are defined as any clinically significant change from baseline as determined by the medical supervisor at the site.
Time Frame
up to 7 days
Title
Frequency of clinically significant changes from baseline in Electrocardiogram (ECG) parameters
Description
Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the medical supervisor at the site.
Time Frame
up to 3 hours after administration of GH001
Title
Change from baseline in the Brief Psychiatric Rating Scale (BPRS)
Description
Change from baseline in the Brief Psychiatric Rating Scale (BPRS). A scale to measure psychiatric symptoms. Each symptom is rated 1-7 and a total of 18 symptoms are scored. Combined score ranges from 18 to 126.
Time Frame
up to 7 days
Title
Change from baseline in the Clinician Administered Dissociative States Scale (CADSS)
Description
Change from baseline in the Clinician Administered Dissociative States Scale (CADSS). The CADSS comprises 19 subjective items, ranging from 0 'not at all' to 4 'extremely. Summed together, these subscales form a total dissociative score. Combined score ranges from 0 to 76.
Time Frame
up to 7 days
Title
Change from baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Change from baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS). A detailed questionnaire assessing both suicidal behaviour and suicidal ideation. No combined score is created.
Time Frame
up to 7 days
Title
Change from baseline in the Psychomotor Vigilance Test (PVT)
Description
Change from baseline in the Psychomotor Vigilance Test (PVT). A computerized test assessing the reaction time in response to a visual stimulus. Outcome measures are Response Time and the number of attentional lapses (Response Time ≥ 500 msec).
Time Frame
up to 7 days
Title
Change from baseline in Digit Symbol Substitution Test (DSST)
Description
Change from baseline in the Digit Symbol Substitution Test (DSST). A computerized test with the task is to match digits with symbols from encoding list. The number of digits correctly encoded within 3 minutes is the performance measure.
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive); Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI); Treatment-Resistant Depression as evaluated by the Antidepressant Treatment History Form - Short Form (ATHF-SF); Has outpatient status at screening and enrolment visits; Exclusion Criteria: Has a current or prior diagnosis of a psychiatric comorbidity that renders the patient unsuitable for the study according to a study psychiatrist or registered psychologist; Has received any investigational medication within the last 1 month; Has a current medically significant condition (e.g., severe infection) or has a history of a medically significant condition (e.g., medical history of seizure, uncontrolled hypertension, uncontrolled diabetes, severe cardiovascular disease, hepatic or renal failure, etc.) that renders the patient unsuitable for the study according to the medical supervisor's judgment; Takes any medication or other substance that renders the patient unsuitable for the study according to the medical supervisor's judgment; Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters, which renders the patient unsuitable for the study according to the medical supervisor's judgment;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GH Research Clinical Team
Organizational Affiliation
GH Research Ireland Limited
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
37409159
Citation
Reckweg JT, van Leeuwen CJ, Henquet C, van Amelsvoort T, Theunissen EL, Mason NL, Paci R, Terwey TH, Ramaekers JG. A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression. Front Psychiatry. 2023 Jun 20;14:1133414. doi: 10.3389/fpsyt.2023.1133414. eCollection 2023.
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Clinical Study of GH001 in Depression

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