IM Ketamine vs Midazolam for Suicidal ER Patients (NCT04640636) | Clinical Trial Compass
SuspendedPhase 4
IM Ketamine vs Midazolam for Suicidal ER Patients
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.
United States90 participantsStarted 2021-02-09
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently suspended — can you find out why it was suspended and whether that raises any safety or effectiveness concerns I should know about before considering ketamine for my situation?
2This study is comparing a single intramuscular dose of ketamine to midazolam for people in the ER with suicidal thoughts — how does that kind of one-time emergency treatment fit into a longer-term plan for managing my depression and suicidal ideation?
3Since this is a Phase 4 trial, meaning ketamine is already approved but being studied in this specific use, what do we already know about the risks of IM ketamine for someone with my type of depression — whether unipolar or bipolar — and are there risks I should weigh carefully?
4The trial measures suicidal ideation using a specific scoring scale called the SSI, but how would we know if any short-term reduction in suicidal thoughts in an ER setting actually translates into meaningful, lasting benefit for me personally?
5Are there standard treatments or other approaches for acute suicidal ideation that you'd recommend I try or consider first, given that this trial is currently suspended and enrollment may not be possible?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.