findmyKOL
Clinical trialNCT04640636SuspendedPhase 4Interventional

IM Ketamine vs Midazolam for Suicidal ER Patients

SponsorNew York State Psychiatric InstituteEnrollment90Depression, BipolarDepression, UnipolarSuicidal Ideation
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Michael Grunebaum, MD

    New York State Psychiatric Institute/Columbia University Irving Medical Center

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Comprehensive Psychiatric Emergency Department of Columbia University Medical Center

    New York, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
9 Feb 2021
Primary completion
30 Sept 2027
Completion
31 Mar 2028
Last update posted
26 May 2026
Registered enrollment
90
Registry id
NCT04640636

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.