Clinical Study of GH001 in Depression

NCT04698603 | Completed Phase 1

• 2 other identifiers: GH001-TRD-1022018-004208-20
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Depression; Major Depressive Disorder; Depression

Keywords

Treatment; 5-MeO-DMT; 5-methoxy-dimethyltryptamine

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 7 days

• 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.

  up to 7 days

Secondary Outcomes (2)

• Phase 1: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)

  up to 7 days

• Phase 2: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13

  up to 7 days

Other Outcomes (9)

• Type and Frequency of Adverse Events

  up to 7 days

• Frequency of clinically significant changes from baseline in the safety laboratory analyses (biochemistry, hematology, urinalysis)

  up to 7 days

• Frequency of clinically significant changes from baseline in Vital Signs

  up to 7 days

Study Arms (3)

Phase 1 (Part A): GH001 dose A

EXPERIMENTAL

Drug: 5 Methoxy N,N Dimethyltryptamine

Phase 1 (Part A): GH001 dose B

EXPERIMENTAL

Drug: 5 Methoxy N,N Dimethyltryptamine

Phase 2 (Part B): GH001 Individualized Dosing Regimen

EXPERIMENTAL

Drug: 5 Methoxy N,N Dimethyltryptamine

Interventions

5 Methoxy N,N Dimethyltryptamine DRUG

GH001 administered via inhalation

Also known as: GH001, 5-MeO-DMT

Phase 1 (Part A): GH001 dose A; Phase 1 (Part A): GH001 dose B; Phase 2 (Part B): GH001 Individualized Dosing Regimen

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• GH Research Ireland Limited: lead

Study Sites (1)

Clinical Trial Site

Maastricht, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37409159 RESULT

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major; Depression

Interventions

Methoxydimethyltryptamines

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

N,N-Dimethyltryptamine; Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Bufotenin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Serotonin

Study Officials

• GH Research Clinical Team

  GH Research Ireland Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 (Part A): Two dose levels of GH001 investigated in single doses. Phase 2 (Part B): GH001 investigated in an individualized dosing regimen.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: January 7, 2021
• Study Start: November 12, 2019
• Primary Completion: November 6, 2021
• Study Completion: November 6, 2021
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)