Treatment Resistant DepressionPhase 1/2NCT04698603

Clinical Study of GH001 in Depression

A Phase 1/2 study testing 5 Methoxy N,N Dimethyltryptamine in people with Treatment Resistant Depression and Major Depressive Disorder, run by GH Research Ireland Limited at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Treatment Resistant Depression, Major Depressive Disorder, Depression
What is being tested?: 5 Methoxy N,N Dimethyltryptamine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteNetherlands
Study dates: 12 Nov 2019to 6 Nov 2021
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Clinical Trial Site
Maastricht

Other trials in Netherlands

About this study

Official title: A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression

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.

Read the 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
Being tested: 5 Methoxy N,N Dimethyltryptamine
Keywords: Treatment, 5-MeO-DMT, 5-methoxy-dimethyltryptamine
Medical subject headings: Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5 Methoxy N,N DimethyltryptamineDrug
Also called GH001, 5-MeO-DMT
GH001 administered via inhalation

Study groups in NCT04698603
Study group	Role	What they receive
Phase 1 (Part A): GH001 dose A	Experimental	Not described Receives: Drug: 5 Methoxy N,N Dimethyltryptamine
Phase 1 (Part A): GH001 dose B	Experimental	Not described Receives: Drug: 5 Methoxy N,N Dimethyltryptamine
Phase 2 (Part B): GH001 Individualized Dosing Regimen	Experimental	Not described Receives: Drug: 5 Methoxy N,N Dimethyltryptamine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
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.
Measured: up to 7 days
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.
Measured: up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 20196 Nov 2021

First posted7 Jan 2021
Study start12 Nov 2019
Primary completion6 Nov 2021
Study completion6 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
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)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04698603
Sponsor's protocol ID: GH001-TRD-102
Other IDs: 2018-004208-20, 2018
Status last verified: Aug 2023
First submitted: 17 Nov 2020
Last updated: 15 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37409159

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Treatment Resistant Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT04698603
Acronym / sponsor ID: GH001-TRD-102
Conditions: Treatment Resistant Depression, Major Depressive Disorder, Depression
Keywords: Treatment, 5-MeO-DMT, 5-methoxy-dimethyltryptamine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: GH Research Ireland LimitedIndustry (pharma, biotech, devices)
Study start: 12 Nov 2019 (actual)
Primary completion: 6 Nov 2021 (actual)
Study completion: 6 Nov 2021 (actual)
First posted: 7 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design: Phase 1/2 study in two parts.

In both parts, GH001 will be administered via inhalation.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
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.

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (5 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
5 Methoxy N,N DimethyltryptamineAlso: GH001, 5-MeO-DMTGH001 administered via inhalation	Drug	Phase 1 (Part A): GH001 dose A, Phase 1 (Part A): GH001 dose B, Phase 2 (Part B): GH001 Individualized Dosing Regimen

Primary outcome

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.

2 secondary outcomes

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 2: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13
Time frame: up to 7 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
Results publication: PubMed 37409159Reckweg 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.
Individual participant dataSharing planned: No

Related trials for Treatment Resistant Depression

Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GH Research Clinical Team study director

GH Research Ireland Limited

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 5 Methoxy N,N Dimethyltryptamine in people with Treatment Resistant Depression and Major Depressive Disorder, run by GH Research Ireland Limited at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13. (time frame: up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04698603, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.