Bipolar II DisorderPhase 2NCT05839509
Phase 2 Clinical Trial of GH001 in Bipolar II Disorder
A Phase 2 study testing GH001 in people with Bipolar II Disorder, run by GH Research Ireland Limited at 7 sites in 3 countries.
Trial summary
This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 participants with clinically diagnosed bipolar disorder (BD) type II and experiencing a current episode of depression will be included in this study. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Bipolar II Disorder
- What is being tested?
- GH001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 6 Apr 2023to 5 Dec 2024
- 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
Who may be able to join
- Is male or female and in the age range between 18 and 64 years (inclusive) at screening
- Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at screening
- Meets the trial criteria for bipolar II disorder and is experiencing a major depressive episode, as assessed by a trial psychiatrist or registered clinical psychologist
Who cannot join
- Has bipolar II disorder with rapid cycling (four or more episodes of hypomania or depressive episodes in previous 12-month period)
- Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar I disorder, a manic episode, a psychotic disorder, MDD or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator's judgment
- Has one or more first degree relatives with a current or previously diagnosed psychotic disorder, bipolar I disorder or MDD with psychotic features
- Has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing
- Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator's judgment
- Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters which renders the patient unsuitable for the trial according to the investigator's judgment
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany3 sites
Investigational Site
Dresden
Investigational Site
Frankfurt
Investigational Site
Münster
Netherlands2 sites
Investigational Site
Leiden
Investigational Site
Maastricht
United Kingdom2 sites
Investigational Site
London
Investigation Site
Oxford
About this study
Official title: A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode
This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 participants with clinically diagnosed bipolar disorder (BD) type II and experiencing a current episode of depression will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.
- Conditions
- Bipolar II Disorder
- Being tested
- GH001
- Keywords
- Depression, Bipolar Disorder, 5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, Mebufotenin
- Medical subject headings
- Bipolar Disorder, 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
| Study group | Role | What they receive |
|---|---|---|
| GH001 Individualized Dosing Regimen | Experimental | GH001 (Mebufotenin, 5-Methoxy-N,N-Dimethyltryptamine) 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7
The MADRS is a ten-item diagnostic questionnaire used to measure 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: From 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.
- First posted3 May 2023
- Study start6 Apr 2023
- Primary completion13 Nov 2024
- Study completion5 Dec 2024
Why it stopped: Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar II DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- GH Research Ireland Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839509
- Sponsor's protocol ID
- GH001-BD-202
- Status last verified
- Feb 2025
- First submitted
- 20 Apr 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode
- ClinicalTrials.gov ID
- NCT05839509
- Acronym / sponsor ID
- GH001-BD-202
- Conditions
- Bipolar II Disorder
- Keywords
- Depression, Bipolar Disorder, 5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, Mebufotenin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GH Research Ireland LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 3 May 2023 (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.
This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 participants with clinically diagnosed bipolar disorder (BD) type II and experiencing a current episode of depression will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GH001 Individualized Dosing Regimen | Experimental | Drug: GH001GH001 (Mebufotenin, 5-Methoxy-N,N-Dimethyltryptamine) 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is male or female and in the age range between 18 and 64 years (inclusive) at screening
- Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at screening
- Meets the trial criteria for bipolar II disorder and is experiencing a major depressive episode, as assessed by a trial psychiatrist or registered clinical psychologist
Key exclusion criteria (6 listed)
- Has bipolar II disorder with rapid cycling (four or more episodes of hypomania or depressive episodes in previous 12-month period)
- Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar I disorder, a manic episode, a psychotic disorder, MDD or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator's judgment
- Has one or more first degree relatives with a current or previously diagnosed psychotic disorder, bipolar I disorder or MDD with psychotic features
- Has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing
- Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator'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 |
|---|---|---|
| GH001Also: 5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, MebufoteninGH001 administered via inhalation | Drug | GH001 Individualized Dosing Regimen |
Primary outcome
The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7
Time frame: From Baseline to Day 7
The MADRS is a ten-item diagnostic questionnaire used to measure 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.
Results and safety
The study was stopped early (reason given: Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GH001 in people with Bipolar II Disorder, run by GH Research Ireland Limited at 7 sites in 3 countries.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Netherlands, United Kingdom. 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 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 was stopped early (reason given: Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population.). Results are not available in the source record.
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?
The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7 (time frame: From Baseline to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.