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Treatment-resistant DepressionPhase 2NCT05800860

A Trial of GH001 in Patients With Treatment-resistant Depression

A Phase 2 study testing GH001 in people with Treatment-resistant Depression, run by GH Research Ireland Limited at 11 sites in 6 countries.

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 this randomized, double-blind, placebo-controlled, phase 2b clinical trial is to investigate the safety and efficacy of GH001 (containing mebufotenin [5-methoxy-N,N-dimethyltryptamine; 5-MeO-DMT]) 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
What is being tested?
GH001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
11 sitesin 6 countries
Study dates
24 May 2023to 11 Mar 2025
Phase
Phase 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

Main Inclusion Criteria:

  1. Is in the age range between 18 and 64 years (inclusive) at the time of informed consent;
  2. Meets the trial criteria for TRD as assessed by a study psychiatrist:
  3. Meets the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI) with current episode duration of ≤2 years;
  4. The current major depressive episode must be deemed "valid" based upon the Massachusetts General Hospital State versus trait Assessability Face and Ecological validity Rule of 3Ps (MGH SAFER) criteria interview;
  5. Had nonresponse (≤25% improvement) to ≥2 and ≤5 oral antidepressant treatments administered during the current episode of depression.

Main Exclusion Criteria:

  1. Has, based on history, psychiatric assessment, and evaluation of the MINI during the screening period, a first MDD episode after age 60, a current or prior diagnosis of a psychotic disorder, MDD, or other mood disorder with psychotic features, bipolar disorder, obsessive compulsive disorder, posttraumatic stress disorder, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, antisocial personality disorder, schizotypal personality disorder, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to a study psychiatrist;
  2. Has significant suicide risk;
  3. Has 1 or more first degree relatives with a current or prior diagnosis of bipolar disorder, psychotic disorder, or other mood disorder (including MDD) with psychotic features;
  4. Undergoing systematic psychotherapy that is planned to be modified or planning to initiate psychotherapy during the trial;
  5. Has any current or past clinically significant condition that may interfere with the interpretation of the trial results, constitute a health risk for the patient, or that otherwise renders the patient unsuitable for the trial according to the investigator's judgement;
  6. Fulfils criteria for DSM-5 alcohol or substance use disorder (excluding tobacco and caffeine use disorders) within the preceding 1 year, as assessed via the MINI;
  7. Is taking antidepressants, antipsychotics, or any medication with monoamine oxidase inhibitors activity or takes or has taken other disallowed recent or concomitant treatments or it is anticipated that the patient will require treatment with at least 1 of the disallowed concomitant treatments during the trial;
  8. Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug (e.g., psilocybin, Psilocybe spp. mushrooms, 5-MeO-DMT, DMT, ayahuasca, lysergic acid diethylamide, mescaline) according to the investigator's judgement.

Trial locations and contacts

11 sites in 6 countries.

11 sites in 6 countries

Germany3 sites

  • Investigational Site

    Dresden

  • Investigational Site

    Frankfurt

  • Investigational Site

    Münster

Other trials in Germany

Czechia2 sites

  • Investigational site

    Pilsen

  • Investigational site

    Prague

Other trials in Czechia

Ireland2 sites

  • Investigational site

    Dublin

  • Investigational Site

    Galway

Other trials in Ireland

Spain2 sites

  • Investigational Site

    Barcelona

  • Investigational Site

    Salamanca

Other trials in Spain

Netherlands1 site

  • Investigational Site

    Maastricht

Other trials in Netherlands

Poland1 site

  • Investigational Site

    Gdansk

Other trials in Poland

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Trial With an Open-label Extension to Determine the Safety and Efficacy of GH001 in Patients With Treatment-resistant Depression

The aim of this randomized, double-blind, placebo-controlled, phase 2b clinical trial is to investigate the safety and efficacy of GH001 (containing mebufotenin [5-methoxy-N,N-dimethyltryptamine; 5-MeO-DMT]) in patients with treatment-resistant depression (TRD). The study is comprised of a 7-day double-blind (DB) part (Part 1) and a 6-month open-label extension (OLE) part (Part 2). Patients will be randomized to receive GH001 or placebo in a 1:1 ratio. The primary endpoint is the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 7.

Read the detailed description

This is a phase 2b clinical trial in patients with TRD consisting of a 7-day randomized, placebo-controlled, DB Part 1 and a 6-month, single-arm, OLE Part 2. All patients who complete the DB Part 1 will directly transition into the OLE Part 2 on Day 7 of the DB Part 1.

In both parts, GH001 is administered as an individualized dosing regimen (IDR) consisting of up to 3 increasing doses of GH001 (6 mg, 12 mg, and 18 mg) on a single day, where the second and third doses are only administered if the patient did not achieve intense psychoactive effects (a peak experience [PE]) at the previously administered dose.

  • In the DB Part 1, patients receive a single GH001 IDR or placebo IDR;
  • In the OLE Part 2, patients can receive up to 5 GH001 IDRs as needed across 6 months, based on the patient's clinical response.

In both parts, an IDR clinic visit on Day (D)0 is followed by a telephone call on D1 and a clinic visit on D7 (±1 day).

The primary objective of this study is to determine the efficacy of a single day IDR of GH001 compared with placebo in improving depressive symptoms as assessed by the MADRS at the end of the 7-day DB Part 1.

Other efficacy objectives of this study are to assess the effects of the GH001 IDR on various measures of depression, anxiety and quality of life during the DB part and during the OLE. The safety of GH001 will also be assessed.

GH001 is an inhalation formulation of synthetic mebufotenin (5-MeO-DMT). The study drug is administered as an aerosol via pulmonary inhalation.

Being tested
GH001, Placebo
Keywords
Treatment-resistant depression, Major depressive disorder, Depression, GH001, 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, Mebufotenin
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.

  • GH001Drug

    Also called 5-Methoxy-N,N-dimethyltryptamine, 5-MeO-DMT, Mebufotenin

    GH001 administered via inhalation

  • PlaceboDrug

    Placebo administered via inhalation

Study groups in NCT05800860
Study groupRoleWhat they receive
GH001 - Part 1ExperimentalGH001 is administered via inhalation, as an IDR consisting of up to 3 increasing doses of GH001 (6 mg, 12 mg, and 18 mg), on a single day. The second and third doses are only administered if the patient did not achieve intense psychoactive effects (a peak experience [PE]) at the previously administered dose.
Receives: Drug: GH001
Placebo - Part 1Placebo comparatorPlacebo is administered via inhalation, as an IDR consisting of up to 3 doses of Placebo, on a single day. The second and third doses are only administered if the patient did not achieve intense psychoactive effects (a PE) at the previously administered dose.
Receives: Drug: Placebo
Open-Label Extension (OLE) - Part 2OtherPatients can receive up to five GH001 IDRs as needed during the OLE based on the patient's clinical response.
Receives: Drug: GH001

What is being measured

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

  1. Mean change in MADRS from Baseline to Day 7

    The assessment is done with the 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: Baseline to Day 7

Timeline

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

  1. First posted6 Apr 2023
  2. Study start24 May 2023
  3. Primary completion4 Oct 2024
  4. Study completion11 Mar 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05800860
Sponsor's protocol ID
GH001-TRD-201
Other IDs
2022-000574-26
Status last verified
May 2025
First submitted
22 Mar 2023
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cubala WJ, Bajbouj M, Bauer M, Baune BT, Cardoner N, Devlin F, Doolin K, Duenas Herrero RM, Elices M, Feeney A, Galuszko-Wegielnik M, Jakuszkowiak-Wojten K, Janu L, Kelly JR, Ledden K, Maclsaac R, Madero S, McInerney SJ, Montejo AL, Nawka A, Palenicek T, Perez Sola V, Ramaekers JG, Reif A, Ritter P, Ryan F, Svendsen CB, Sweeney C, Terwey TH, Trivedi MH, Valcheva V, Vieta E, Thase ME. GH001 vs Placebo in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Jun 1;83(6):561-569. doi: 10.1001/jamapsychiatry.2026.0096.

    PubMed 41879760

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GH001 in people with Treatment-resistant Depression, run by GH Research Ireland Limited at 11 sites in 6 countries.

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

Who may be eligible to take part?

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 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany, Czechia, Ireland, Spain, Netherlands and 1 more country. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Mean change in MADRS from Baseline to Day 7 (time frame: Baseline to Day 7). 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 NCT05800860, 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 31 May 2025.

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