Major Depressive Disorder (MDD)Phase 4NCT07139106
Understanding the Role of the Kappa Opioid Receptor in Ketamine's Attenuation of Suicidal Thoughts
A Phase 4 study testing Ketamine hydrochloride infusion in people with Major Depressive Disorder (MDD), run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study explores how stress, suicidal thoughts, and ketamine's effects are connected in people with major depressive disorder. Stress increases the risk for suicidal thoughts, but the biological basis is unclear. Ketamine may help reduce suicidal thoughts by affecting stress-linked brain systems. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Ketamine hydrochloride infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- DSM5 unipolar major depressive episode
- Persons of child-bearing potential must agree to use an acceptable method of birth control throughout the study.
Who cannot join
- Current or past ketamine abuse or dependence ever (lifetime)
- Any medical contraindication to ketamine, including prior ineffective trial of or medically significant adverse reaction to ketamine.
- Clinically significant EKG abnormality in terms of ketamine administration (e.g., Ventricular tachycardia, evidence of myocardial ischemia, symptomatic bradycardia, unstable tachycardia, second degree (or greater) AV block).
- Lifetime schizophrenia, schizoaffective illness, bipolar disorder, current psychotic depression; mild drug or alcohol use disorder in past 2 months; moderate or severe drug or alcohol use disorder in past 6 months; suicidal ideation with plan and/or intent within 6 months; suicide attempt in the past month.
- A first-degree family history of schizophrenia if the subject is less than 33 years old (mean age of onset for schizophrenia plus two standard deviations).
- Current or recent use of antidepressants within 14 days or benzodiazepines within 1 day. Use of fluoxetine or other long-acting antidepressant within 6 weeks.
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- Current or recent use of medications known to affect brain biology of interest such as competing for binding sites of PET tracer within 1 month.
- Uncontrolled moderate or severe hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic[41]), history of Raynaud's phenomenon, seizures, an open cut, sore, or bone fracture on or near the hands to be used for the cold pressor test.
- Use of more than incidental NSAIDs (including aspirin), anti-inflammatories, immune suppressants or other pain medications.
- Significant active physical illness, particularly if it may affect the brain biology being studied; including chronic pain syndrome and medically compromising eating disorders or epilepsy.
- Lacks capacity to consent
- Aggressive behavior that is a significant threat to others such as physically assaultive behavior (in the last month).
- Pregnancy, abortion or miscarriage in the previous two months or plans to conceive during the course of study participation.
- Currently lactating
- Previous head injury with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score 1.5 standard deviations below the mean on Trail-making A or B will be excluded from study participation.
- Any condition or material in the body that is a contraindication for MRI procedures.
- Current, past or anticipated exposure to radiation except if the exposure was at our PET center where the precise exposure is known
- ECT within past 6 months
- For A-Line Subjects: Unstable relevant medical condition (i.e., condition not adequately stabilized for 3 months). Including bleeding disorders, the need to take medications that affect blood clotting, and certain platelet and hemoglobin cutoffs
- Blind or with visual impairment that cannot be corrected with corrective lenses (glasses or contact lenses)
- No emergency contact
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Dynorphin/Kappa Opioid Receptor Signaling Role in Ketamine's Anti-suicidal Ideation Effect
This study explores how stress, suicidal thoughts, and ketamine's effects are connected in people with major depressive disorder. Stress increases the risk for suicidal thoughts, but the biological basis is unclear. Ketamine may help reduce suicidal thoughts by affecting stress-linked brain systems. This study will use smartphone tracking to monitor real-time responses to stress and positron emission tomography (PET) brain scans to study how ketamine affects brain pathways related to stress and suicidal thoughts in depressed individuals.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Ketamine hydrochloride infusion
- Keywords
- ketamine, positron emission tomography (PET), kappa opioid receptor, major depressive disorder (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.
Ketamine hydrochloride infusionDrug
single racemic ketamine hydrochloride 0.5 mg/kg infusion
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | single racemic ketamine hydrochloride 0.5 mg/kg infusion Receives: Drug: Ketamine hydrochloride infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for Suicidal Ideation (SSI)
Beck Scale for Suicidal Ideation clinician-rated version. Minimum score = 0, Maximum score = 38. Higher scores mean a worse outcome.
Measured: 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Elizabeth Bartlett, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139106
- Sponsor's protocol ID
- Pro00089428
- Other IDs
- ECR-0-013-24
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All associated research findings published will be made readily available for research purposes to qualified individuals within the scientific community. All data will be made anonymous (de-identified) and available after written requests for data are submitted by such qualified individuals to the PI.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynorphin/Kappa Opioid Receptor Signaling Role in Ketamine's Anti-suicidal Ideation Effect
- ClinicalTrials.gov ID
- NCT07139106
- Acronym / sponsor ID
- Pro00089428
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- ketamine, positron emission tomography (PET), kappa opioid receptor, major depressive disorder (MDD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 24 Aug 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.
This study explores how stress, suicidal thoughts, and ketamine's effects are connected in people with major depressive disorder. Stress increases the risk for suicidal thoughts, but the biological basis is unclear. Ketamine may help reduce suicidal thoughts by affecting stress-linked brain systems. This study will use smartphone tracking to monitor real-time responses to stress and positron emission tomography (PET) brain scans to study how ketamine affects brain pathways related to stress and suicidal thoughts in depressed individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine hydrochloride infusionsingle racemic ketamine hydrochloride 0.5 mg/kg infusion |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- DSM5 unipolar major depressive episode
- Persons of child-bearing potential must agree to use an acceptable method of birth control throughout the study.
Key exclusion criteria (21 listed)
- Current or past ketamine abuse or dependence ever (lifetime)
- Any medical contraindication to ketamine, including prior ineffective trial of or medically significant adverse reaction to ketamine.
- Clinically significant EKG abnormality in terms of ketamine administration (e.g., Ventricular tachycardia, evidence of myocardial ischemia, symptomatic bradycardia, unstable tachycardia, second degree (or greater) AV block).
- Lifetime schizophrenia, schizoaffective illness, bipolar disorder, current psychotic depression; mild drug or alcohol use disorder in past 2 months; moderate or severe drug or alcohol use disorder in past 6 months; suicidal ideation with plan and/or intent within 6 months; suicide attempt in the past month.
- A first-degree family history of schizophrenia if the subject is less than 33 years old (mean age of onset for schizophrenia plus two standard deviations).
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 hydrochloride infusionsingle racemic ketamine hydrochloride 0.5 mg/kg infusion | Drug | Ketamine |
Primary outcome
Scale for Suicidal Ideation (SSI)
Time frame: 24 hours post-treatment
Beck Scale for Suicidal Ideation clinician-rated version. Minimum score = 0, Maximum score = 38. Higher scores mean a worse outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. All associated research findings published will be made readily available for research purposes to qualified individuals within the scientific community. All data will be made anonymous (de-identified) and available after written requests for data are submitted by such qualified individuals to the PI.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine hydrochloride infusion in people with Major Depressive Disorder (MDD), run by New York State Psychiatric Institute 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 21 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: opening soon, as of the sponsor's last update on 3 Aug 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth A Bartlett, PhD (646-774-7608, BartlettMINDResearch@nyspi.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Suicidal Ideation (SSI) (time frame: 24 hours post-treatment). 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 3 Aug 2026.