Depression, UnipolarPhase 4NCT04640636
IM Ketamine vs Midazolam for Suicidal ER Patients
A Phase 4 study testing Ketamine hydrochloride injection and Midazolam injection in people with Depression, Unipolar and Depression, Bipolar, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Unipolar, Depression, Bipolar, Suicidal Ideation
- What is being tested?
- Ketamine hydrochloride injection and Midazolam injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to Mar 2028
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM5 unipolar or bipolar (I, II, or Unspecified) major depressive episode
- Presenting to emergency department and assessed by psychiatrist staff as needing inpatient treatment due to suicidality
- Participant agrees to voluntary inpatient psychiatric admission
- Beck Scale for Suicidal Ideation score of 4 or higher
Who cannot join
- Substance use disorder in past 2 weeks
- Current psychosis or mania
- Intellectual disability
- Inadequate understanding of English and/or lack of capacity for informed consent
- Pregnancy or lactation
- Medical contraindication to ketamine or midazolam
- Unstable medical or neurological illness such as uncontrolled hypertension, significant cardiac arrhythmia, unstable cerebrovascular disease. Chronic, stable medical conditions such as controlled hypertension or diabetes will not be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Psychiatric Emergency Department of Columbia University Medical Center
New York, New York, 10032
About this study
Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. There is no approved treatment for rapid relief of suicidal thoughts although clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, sub-anesthetic ketamine. We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement.
NOTE: The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023.
Read more
The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
Non-HHS Studies: The IO in concurrence with the IRB paused human subjects research on June 12, 2023. Therefore, the NYSPI site is not enrolling at this time.
Read the detailed description
Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. Clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, subanesthetic ketamine. We have received NIMH R01 funding to conduct a clinical trial of intramuscular (IM) ketamine in unipolar or bipolar depressed adults who present to the CUIMC psychiatric ED with suicidality severe enough to require inpatient hospitalization as judged by ED clinical staff. Clinical staff will ask potentially eligible patients if they would like to learn more about the study, and if so, a research assistant (RA) will describe the study to the patient and perform a basic eligibility screen. Key exclusions are unstable medical problems, substance abuse, psychosis, and further detail is provided in the Inclusion/Exclusion criteria. Participants (N=90) who enroll will undergo baseline clinical ratings, brief cognitive testing, and then be randomized, double-blind, in a 2:1 ratio to a single IM injection of ketamine (n=60) or midazolam comparator (n=30). Vital signs and clinical state will be monitored until injection effects subside (approximately 2 hrs). Blood samples will be drawn at 60 minutes and 90 minutes postinjection to assay ketamine level and a genetic sample will be stored. All participants will then be admitted to the 9GN inpatient unit for standard clinical treatment with periodic research follow-up ratings through 4 weeks post-discharge from hospital. Ongoing outpatient treatment will be arranged by the inpatient clinical team. Positive results from this trial would support a novel, easy-to-use, inexpensive, and scalable intervention for busy emergency clinicians to implement.
- Conditions
- Depression, Unipolar, Depression, Bipolar, Suicidal Ideation
- Being tested
- Ketamine hydrochloride injection, Midazolam injection
- Keywords
- depression, suicidality, clinical trial, ketamine, midazolam
- Medical subject headings
- Depressive Disorder, Bipolar Disorder, Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine hydrochloride injectionDrug
single IM injection of ketamine hydrochloride 0.5 mg/kg
Midazolam injectionDrug
single IM injection of midazolam 0.06 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Ketamine hydrochloride 0.5 mg/kg IM single injection Receives: Drug: Ketamine hydrochloride injection |
| midazolam | Active comparator | Midazolam 0.06 mg/kg IM single injection Receives: Drug: Midazolam injection |
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
Measured: 24 hours post-treatment
Secondary outcomes (1)
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Frequency of adverse events at 24 hours post-treatment
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 posted23 Nov 2020
- Study start9 Feb 2021
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Why it stopped: The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, UnipolarStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael Grunebaum, MD, New York State Psychiatric Institute
- Investigators
- Michael Grunebaum, MD, Principal investigator, New York State Psychiatric Institute/Columbia University Irving Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640636
- Sponsor's protocol ID
- 8070-76595
- Other IDs
- R01MH125155-01
- Status last verified
- May 2026
- First submitted
- 20 Nov 2020
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All associated research findings published or provided to NIH, will be made readily available for research purposes to qualified individuals within the scientific community. All data will be made anonymous 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IM Ketamine vs Midazolam for Suicidal ER Patients
- ClinicalTrials.gov ID
- NCT04640636
- Acronym / sponsor ID
- 8070-76595
- Conditions
- Depression, Unipolar, Depression, Bipolar, Suicidal Ideation
- Keywords
- depression, suicidality, clinical trial, ketamine, midazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Nov 2020 (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.
Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. There is no approved treatment for rapid relief of suicidal thoughts although clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, sub-anesthetic ketamine. We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement.
NOTE: The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023.
The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
Non-HHS Studies: The IO in concurrence with the IRB paused human subjects research on June 12, 2023. Therefore, the NYSPI site is not enrolling at this time.
Detailed description
Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. Clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, subanesthetic ketamine. We have received NIMH R01 funding to conduct a clinical trial of intramuscular (IM) ketamine in unipolar or bipolar depressed adults who present to the CUIMC psychiatric ED with suicidality severe enough to require inpatient hospitalization as judged by ED clinical staff. Clinical staff will ask potentially eligible patients if they would like to learn more about the study, and if so, a research assistant (RA) will describe the study to the patient and perform a basic eligibility screen. Key exclusions are unstable medical problems, substance abuse, psychosis, and further detail is provided in the Inclusion/Exclusion criteria. Participants (N=90) who enroll will undergo baseline clinical ratings, brief cognitive testing, and then be randomized, double-blind, in a 2:1 ratio to a single IM injection of ketamine (n=60) or midazolam comparator (n=30). Vital signs and clinical state will be monitored until injection effects subside (approximately 2 hrs). Blood samples will be drawn at 60 minutes and 90 minutes postinjection to assay ketamine level and a genetic sample will be stored. All participants will then be admitted to the 9GN inpatient unit for standard clinical treatment with periodic research follow-up ratings through 4 weeks post-discharge from hospital. Ongoing outpatient treatment will be arranged by the inpatient clinical team. Positive results from this trial would support a novel, easy-to-use, inexpensive, and scalable intervention for busy emergency clinicians to implement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine hydrochloride injectionKetamine hydrochloride 0.5 mg/kg IM single injection |
| midazolam | Active comparator | Drug: Midazolam injectionMidazolam 0.06 mg/kg IM single injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM5 unipolar or bipolar (I, II, or Unspecified) major depressive episode
- Presenting to emergency department and assessed by psychiatrist staff as needing inpatient treatment due to suicidality
- Participant agrees to voluntary inpatient psychiatric admission
- Beck Scale for Suicidal Ideation score of 4 or higher
Key exclusion criteria (7 listed)
- Substance use disorder in past 2 weeks
- Current psychosis or mania
- Intellectual disability
- Inadequate understanding of English and/or lack of capacity for informed consent
- Pregnancy or lactation
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 injectionsingle IM injection of ketamine hydrochloride 0.5 mg/kg | Drug | Ketamine |
| Midazolam injectionsingle IM injection of midazolam 0.06 mg/kg | Drug | midazolam |
Primary outcome
Scale for Suicidal Ideation (SSI)
Time frame: 24 hours post-treatment
Beck Scale for Suicidal Ideation clinician-rated version
1 secondary outcome
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time frame: 24 hours post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes. All associated research findings published or provided to NIH, will be made readily available for research purposes to qualified individuals within the scientific community. All data will be made anonymous 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. This study is not recruiting at the moment.
Michael Grunebaum, MD principal investigator
New York State Psychiatric Institute/Columbia University Irving Medical Center
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 injection and Midazolam injection in people with Depression, Unipolar and Depression, Bipolar, 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 4 inclusion and 7 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: paused, as of the sponsor's last update on 26 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 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?
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?
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 26 May 2026.