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IM Ketamine vs Midazolam for Suicidal ER Patients
Sponsor: New York State Psychiatric Institute
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2021-02-09
Completion Date
2028-03
Last Updated
2026-05-26
Healthy Volunteers
No
Interventions
Ketamine hydrochloride injection
single IM injection of ketamine hydrochloride 0.5 mg/kg
Midazolam injection
single IM injection of midazolam 0.06 mg/kg
Locations (1)
Comprehensive Psychiatric Emergency Department of Columbia University Medical Center
New York, New York, United States