Clinical Study of GH001 in Depression

NCT ID: NCT04698603

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-12
• Study Completion Date: 2021-11-06

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.

Conditions

Treatment Resistant Depression; Major Depressive Disorder; Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 (Part A): GH001 dose A

Group Type: EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type: DRUG

GH001 administered via inhalation

Phase 1 (Part A): GH001 dose B

Group Type: EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type: DRUG

GH001 administered via inhalation

Phase 2 (Part B): GH001 Individualized Dosing Regimen

Group Type: EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type: DRUG

GH001 administered via inhalation

Interventions

5 Methoxy N,N Dimethyltryptamine

GH001 administered via inhalation

Intervention Type: DRUG

Other Intervention Names

GH001; 5-MeO-DMT

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GH Research Ireland Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GH Research Clinical Team

Role: STUDY_DIRECTOR

GH Research Ireland Limited

Locations

Clinical Trial Site

Maastricht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: RESULT

PMID: 37409159 (View on PubMed)

Other Identifiers

2018-004208-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GH001-TRD-102

Identifier Type: -

Identifier Source: org_study_id