Treatment Resistant Depression (TRD)Phase 1NCT07307768
Ketamine Biomarker Validation
A Phase 1 study testing Ketamine (0.25 mg/kg), Ketamine (0.5 mg/kg) and Ketamine (0.75 mg/kg) in people with Treatment Resistant Depression (TRD), run by Soterix Medical at 1 site in United States.
Trial summary
An EEG-based biomarker will be developed for the effects of ketamine infusion in patients with Depression. The effects of ketamine infusion on Depression symptoms and EEG signals will be analyzed. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Treatment Resistant Depression (TRD)
- What is being tested?
- Ketamine (0.25 mg/kg), Ketamine (0.5 mg/kg) and Ketamine (0.75 mg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2025to 1 Mar 2028
- Phase
- Phase 1
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physically healthy patients who meet DMS-5 criteria for a major depressive episode (MDE) in the context of MDD and who score at least 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
- If taking antidepressants, dose is stable for at least 6 weeks.
Who cannot join
- Lifetime history of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder, including MDD with psychotic features
- A first-degree relative with bipolar disorder, schizoaffective disorder, or schizophrenia, with the potential participant younger than 33 years (i.e., still at age of risk for a psychotic disorder)
- Receipt of electroconvulsive therapy within 3 months of enrolling in the study
- History of IV drug use
- Nonresponse or intolerance to ketamine administered either clinically or as part of a prior research study
- Pregnancy, planning to conceive, or sexually active but not using adequate birth control.
- Actively suicidal (CSSRS≥3)
- No antipsychotics or medications (e.g. benzodiazepines, anti-epileptics) that are likely to interact with GABA or glutamate,
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: EEG Biomarker Development for Ketamine Administration
An EEG-based biomarker will be developed for the effects of ketamine infusion in patients with Depression. The effects of ketamine infusion on Depression symptoms and EEG signals will be analyzed.
Read the detailed description
This trial is a biomarker development study. The effects of various doses of ketamine infusion on depressive symptoms and EEG signals in patients with unipolar depression will be analyzed.
- Conditions
- Treatment Resistant Depression (TRD)
- Being tested
- Ketamine (0.25 mg/kg), Ketamine (0.5 mg/kg), Ketamine (0.75 mg/kg)
- Keywords
- Ketamine, EEG, Depression, MDD, unipolar Depression, Biomarker
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (0.25 mg/kg)Drug
Low level ketamine infusion therapy.
Ketamine (0.5 mg/kg)Drug
Medium level ketamine infusion therapy.
Ketamine (0.75 mg/kg)Drug
High level ketamine infusion therapy.
| Study group | Role | What they receive |
|---|---|---|
| Low level ketamine | Experimental | 0.25 mg/kg ketamine infusion Receives: Drug: Ketamine (0.25 mg/kg) |
| Medium level ketamine | Experimental | 0.5 mg/kg ketamine infusion Receives: Drug: Ketamine (0.5 mg/kg) |
| High level ketamine | Experimental | 0.75 mg/kg ketamine infusion Receives: Drug: Ketamine (0.75 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS) 22
Twenty-two question Depression rating scale (excluding the two questions on weight loss and diurnal variation)
Measured: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72
Secondary outcomes (3)
The Columbia Suicidality Severity Rating Scale (C-SSRS)
A semi-structured, investigator-rated interview assessing both suicidal behavior and suicidal ideation.
Measured: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72
The Clinician Administered Dissociative States Scale (CADSS)
A scale that rates dissociative symptoms with a 27-item scale, rated 0-4, 19 subjective, and 8 observer items
Measured: Baseline, and Hour 1
Montgomery-Asberg Depression Rating Scale (MADRS)
A ten-item diagnostic used for the assessment of depression severity
Measured: Baseline and Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Why it stopped: Funding was not provided
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Depression (TRD)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soterix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307768
- Sponsor's protocol ID
- KETAEEG
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Biomarker Development for Ketamine Administration
- ClinicalTrials.gov ID
- NCT07307768
- Acronym / sponsor ID
- KETAEEG
- Conditions
- Treatment Resistant Depression (TRD)
- Keywords
- Ketamine, EEG, Depression, MDD, unipolar Depression, Biomarker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not provided
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Soterix MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Columbia University
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 29 Dec 2025 (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.
An EEG-based biomarker will be developed for the effects of ketamine infusion in patients with Depression. The effects of ketamine infusion on Depression symptoms and EEG signals will be analyzed.
Detailed description
This trial is a biomarker development study. The effects of various doses of ketamine infusion on depressive symptoms and EEG signals in patients with unipolar depression will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low level ketamine | Experimental | Drug: Ketamine (0.25 mg/kg)0.25 mg/kg ketamine infusion |
| Medium level ketamine | Experimental | Drug: Ketamine (0.5 mg/kg)0.5 mg/kg ketamine infusion |
| High level ketamine | Experimental | Drug: Ketamine (0.75 mg/kg)0.75 mg/kg ketamine infusion |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physically healthy patients who meet DMS-5 criteria for a major depressive episode (MDE) in the context of MDD and who score at least 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
- If taking antidepressants, dose is stable for at least 6 weeks.
Key exclusion criteria (8 listed)
- Lifetime history of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder, including MDD with psychotic features
- A first-degree relative with bipolar disorder, schizoaffective disorder, or schizophrenia, with the potential participant younger than 33 years (i.e., still at age of risk for a psychotic disorder)
- Receipt of electroconvulsive therapy within 3 months of enrolling in the study
- History of IV drug use
- Nonresponse or intolerance to ketamine administered either clinically or as part of a prior research study
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 |
|---|---|---|
| Ketamine (0.25 mg/kg)Low level ketamine infusion therapy. | Drug | Low level ketamine |
| Ketamine (0.5 mg/kg)Medium level ketamine infusion therapy. | Drug | Medium level ketamine |
| Ketamine (0.75 mg/kg)High level ketamine infusion therapy. | Drug | High level ketamine |
Primary outcome
Hamilton Depression Rating Scale (HDRS) 22
Time frame: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72
Twenty-two question Depression rating scale (excluding the two questions on weight loss and diurnal variation)
3 secondary outcomes
The Columbia Suicidality Severity Rating Scale (C-SSRS)
Time frame: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72
The Clinician Administered Dissociative States Scale (CADSS)
Time frame: Baseline, and Hour 1
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and Hour 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine (0.25 mg/kg), Ketamine (0.5 mg/kg) and Ketamine (0.75 mg/kg) in people with Treatment Resistant Depression (TRD), run by Soterix Medical at 1 site in United States.
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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 19 Oct 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 States. 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 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.
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 withdrawn before enrolling participants, so there are no results.
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?
Hamilton Depression Rating Scale (HDRS) 22 (time frame: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72). 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 19 Oct 2026.