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Clinical Study of GH001 in Depression

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ClinicalTrials.gov Identifier: NCT04698603
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
GH Research Limited

Tracking Information
First Submitted Date  ICMJE November 17, 2020
First Posted Date  ICMJE January 7, 2021
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE November 12, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2021)
  • Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13. [ Time Frame: up to 7 days ]
    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) [ Time Frame: up to 7 days ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2021)
  • Phase 1: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: up to 7 days ]
    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 [ Time Frame: up to 7 days ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 6, 2021)
  • Type and Frequency of Adverse Events [ Time Frame: up to 7 days ]
    Adverse events reported in the study and coded by MedDRA.
  • Frequency of clinically significant changes from baseline in the safety laboratory analyses (biochemistry, hematology, urinalysis) [ Time Frame: up to 7 days ]
    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.
  • Frequency of clinically significant changes from baseline in Vital Signs [ Time Frame: up to 7 days ]
    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.
  • Frequency of clinically significant changes from baseline in Electrocardiogram (ECG) parameters [ Time Frame: up to 3 hours after administration of GH001 ]
    Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the medical supervisor at the site.
  • Change from baseline in the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: up to 7 days ]
    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.
  • Change from baseline in the Clinician Administered Dissociative States Scale (CADSS) [ Time Frame: up to 7 days ]
    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.
  • Change from baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: up to 7 days ]
    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.
  • Change from baseline in the Psychomotor Vigilance Test (PVT) [ Time Frame: up to 7 days ]
    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).
  • Change from baseline in Digit Symbol Substitution Test (DSST) [ Time Frame: up to 7 days ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Study of GH001 in Depression
Official Title  ICMJE A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Treatment Resistant Depression
  • Major Depressive Disorder
  • Depression
Intervention  ICMJE Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Study Arms  ICMJE
  • Experimental: Phase 1 (Part A): GH001 dose A
    Intervention: Drug: 5 Methoxy N,N Dimethyltryptamine
  • Experimental: Phase 1 (Part A): GH001 dose B
    Intervention: Drug: 5 Methoxy N,N Dimethyltryptamine
  • Experimental: Phase 2 (Part B): GH001 Individualized Dosing Regimen
    Intervention: Drug: 5 Methoxy N,N Dimethyltryptamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2021)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: GH Research Clinical Team No study phone clinicaltrials@ghres.com
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04698603
Other Study ID Numbers  ICMJE GH001-MDD-102
2018-004208-20 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GH Research Limited
Study Sponsor  ICMJE GH Research Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GH Research Clinical Team GH Research Limited
PRS Account GH Research Limited
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP