Major Depressive DisorderPhase 2NCT06309277
A Clinical Study to Evaluate of Single and Multiple Oral Doses of GM-1020 in Patients With MDD
A Phase 2 study testing GM-1020 in people with Major Depressive Disorder, run by Gilgamesh Pharmaceuticals at 1 site in United Kingdom.
Trial summary
The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- GM-1020
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2024to 27 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is male or female, of any ethnic origin.
- Patient is aged between 18 to 65 years, inclusive.
- Patient has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
- Patient is ≥50 kg.
- Patient meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for recurrent MDD without psychotic features based on the Mini-International Neuropsychiatric Interview (MINI) at Screening. Comorbid anxiety disorders (e.g., social anxiety disorder, panic disorder, generalised anxiety disorder, specific phobia, agoraphobia) and cluster C personality disorders (avoidant, dependent and obsessive-compulsive) are allowed, provided that MDD is considered the primary diagnosis.
- Current moderate to severe MDD as confirmed with a MADRS-SIGMA total score >22 and CGI-S score >3 at Screening and Day -1.
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- Patient is either not currently taking antidepressants (and hasn't for at least 6 weeks prior to Screening) or is being treated with an SSRI or SNRI antidepressant drug according to national guidelines during the current MDD episode.
- If the patient is currently being treated with SSRI or SNRI antidepressants, these have been prescribed at a stable dose and the dose has remained unchanged for at least 6 weeks prior to Screening. However, the following medications are not permitted during the study at any time: NMDA receptor antagonists (including ketamine, esketamine) and 5-HT2A receptor agonists (including psilocybin, DMT, 5-MeO-DMT). No augmentation strategies will be permitted.
- Changes in current drug treatment or psychological treatment for depression are not foreseen for the duration of the study.
Who cannot join
- Current or recent history of clinically significant suicidal ideation or behaviours as defined by:
- Suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within 6 months prior to Screening, or
- Suicidal behaviours within 1 year prior to Screening, or
- Clinical assessment of significant suicidal risk. Patients with a prior suicide attempt of any sort, or prior serious suicidal ideation/plan >6 months ago, should be carefully screened for current suicidal ideation and only included at the discretion of the Investigator.
- Involuntary psychiatric hospitalisation in the current episode. Previous involuntary psychiatric hospitalisation should be carefully considered and only included at the discretion of the Investigator.
- Lifetime diagnosis of any DSM-5 psychotic disorders, bipolar or related disorders, post-traumatic stress disorder (PTSD), complex-PTSD and borderline personality disorder. Other psychiatric disorders besides MDD should not be the primary disorder.
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- Patient has failed previous treatment with rapidly acting antidepressant drugs, such as NMDA receptor antagonists (e.g., ketamine, esketamine) or 5-HT2A receptor agonists (e.g., psilocybin, DMT, 5-MeO-DMT) or neuromodulating treatments, such as electroconvulsive therapy, transcranial magnetic stimulation, vagus nerve stimulation, or deep brain stimulation.
- Patient is currently or has recently (within 6 weeks prior to Day 1) been treated with antipsychotic medication.
- Use of psychoactive substances (including ketamine, esketamine or psychedelics, excluding cannabis) during the 6 weeks prior to Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part Controlled Clinical Study to Evaluate Safety, Tolerability, Response, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of GM-1020 in Patients With Major Depressive Disorder
The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy.
- Conditions
- Major Depressive Disorder
- Being tested
- GM-1020
- Keywords
- MDD
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-1020Drug
N-methyl-D-aspartate (NMDA) receptor antagonist
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | GM-1020 (oral) Receives: Drug: GM-1020 |
| Placebo | Placebo comparator | Placebo (oral) Receives: Drug: GM-1020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
Clinical monitoring of safety data from AE reporting, 12-lead ECG, vital signs, clinical laboratory evaluations, emergence of suicidal thoughts and ideations (Columbia-Suicidal Severity Rating Scale) and sedation (Modified Observer's Assessment of Alertness and Sedation).
Measured: Baseline, Day 29
Secondary outcomes (2)
MADRS Total Score Change From Baseline to 24 Hours
The Structured Interview Guide for the Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to assess the severity of depressive symptoms in patients. It consists of 10 items, each scored from 0 to 6, yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity. Part A change from baseline MADRS was analyzed for Period 1 due to carryover effects as per SAP-defined analysis.
Measured: Baseline, 24 hours
MADRS Total Score Change From Baseline to Day 8
The Structured Interview Guide for the Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to assess the severity of depressive symptoms in patients. It consists of 10 items, each scored from 0 to 6, yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity. Part A change from baseline MADRS was analyzed for Period 1 due to carryover effects as per SAP-defined analysis.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Feb 2024
- Primary completion4 Mar 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilgamesh Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Marek, MD, Study chair, Gilgamesh Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309277
- Sponsor's protocol ID
- GLG-100X
- Status last verified
- May 2026
- First submitted
- 29 Jan 2024
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Controlled Clinical Study to Evaluate Safety, Tolerability, Response, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of GM-1020 in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06309277
- Acronym / sponsor ID
- GLG-100X
- Conditions
- Major Depressive Disorder
- Keywords
- MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Gilgamesh PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Posted 8 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: GM-1020GM-1020 (oral) |
| Placebo | Placebo comparator | Drug: GM-1020Placebo (oral) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is male or female, of any ethnic origin.
- Patient is aged between 18 to 65 years, inclusive.
- Patient has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
- Patient is ≥50 kg.
- Patient meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for recurrent MDD without psychotic features based on the Mini-International Neuropsychiatric Interview (MINI) at Screening. Comorbid anxiety disorders (e.g., social anxiety disorder, panic disorder, generalised anxiety disorder, specific phobia, agoraphobia) and cluster C personality disorders (avoidant, dependent and obsessive-compulsive) are allowed, provided that MDD is considered the primary diagnosis.
Key exclusion criteria (9 listed)
- Current or recent history of clinically significant suicidal ideation or behaviours as defined by:
- Involuntary psychiatric hospitalisation in the current episode. Previous involuntary psychiatric hospitalisation should be carefully considered and only included at the discretion of the Investigator.
- Lifetime diagnosis of any DSM-5 psychotic disorders, bipolar or related disorders, post-traumatic stress disorder (PTSD), complex-PTSD and borderline personality disorder. Other psychiatric disorders besides MDD should not be the primary disorder.
- Patient has failed previous treatment with rapidly acting antidepressant drugs, such as NMDA receptor antagonists (e.g., ketamine, esketamine) or 5-HT2A receptor agonists (e.g., psilocybin, DMT, 5-MeO-DMT) or neuromodulating treatments, such as electroconvulsive therapy, transcranial magnetic stimulation, vagus nerve stimulation, or deep brain stimulation.
- Patient is currently or has recently (within 6 weeks prior to Day 1) been treated with antipsychotic medication.
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 |
|---|---|---|
| GM-1020N-methyl-D-aspartate (NMDA) receptor antagonist | Drug | Active, Placebo |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: Baseline, Day 29
Clinical monitoring of safety data from AE reporting, 12-lead ECG, vital signs, clinical laboratory evaluations, emergence of suicidal thoughts and ideations (Columbia-Suicidal Severity Rating Scale) and sedation (Modified Observer's Assessment of Alertness and Sedation).
2 secondary outcomes
MADRS Total Score Change From Baseline to 24 Hours
Time frame: Baseline, 24 hours
MADRS Total Score Change From Baseline to Day 8
Time frame: Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gerard Marek, MD study chair
Gilgamesh Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-1020 in people with Major Depressive Disorder, run by Gilgamesh Pharmaceuticals at 1 site in United Kingdom.
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 9 inclusion and 9 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 8 May 2026. 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 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. 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?
Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Treatment Emergent Adverse Events (time frame: Baseline, Day 29). 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 8 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.