# IM Ketamine for rapid reduction of suicidal thoughts in high-risk emergency room patients: a midazolam-controlled trial

> **NIH NIH R01** · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · 2022 · $575,915

## Abstract

Project Summary/Abstract
 US suicide rates rose more than 30% from 1999 – 2017. Individuals who visit an emergency department
(ED) for deliberate self-harm or suicidal thoughts have suicide rates within a year that are 57 and 31 times
greater, respectively, than age-, sex-, and race/ethnicity-adjusted general population groups. This targets the
ED as a key setting to intervene to reduce suicide risk. Yet, there is no U.S. Food and Drug Administration (FDA)
approved treatment for rapid relief of suicidal thoughts in depressed patients. This is even though randomized
clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with sub-anesthetic
ketamine. Our published, controlled clinical trials in bipolar and unipolar suicidal depressed patients found that
ketamine reduced suicidal thoughts within hours and the improvement persisted for up to six weeks with
optimized, standard pharmacotherapy. During the two years 2017-18 there were more than 2 million ED visits
for suicidal ideation, self-directed violence, or both. Patients are at greater risk for suicide attempts and suicide
after an ED visit. A rapid, safe, and easy-to-use treatment for patients presenting to an ED with severe suicidal
thoughts or behavior would advance public health. There has not yet been a definitive study of readily available
generic ketamine for rapid reduction of suicidal thoughts in ED patients. A key military recommendation for
battlefield analgesia is ketamine 50-100 mg intramuscular (im) injection, similar to effective intravenous (iv)
doses used for depression. Onset of clinical effects is about 1 minute with iv and 5 minutes with im injection. IM
ketamine is 93% bioavailable in adult humans and has a plasma half-life similar to iv administration. A clinical
trial demonstrating feasibility, safety, and effectiveness of im, generic ketamine for rapid reduction of suicidal
thoughts in ED patients would support a novel, scalable, easy-to-use treatment for this population. We propose
to conduct a trial of im ketamine versus im midazolam (an active comparator used in our prior ketamine trials) in
ED patients presenting with severe suicidal ideation or behavior requiring psychiatric hospitalization. The primary
outcomes will be feasibility, safety, and reduction of suicidal thoughts within 24 hours. Secondary outcomes will
include effects on length of stay, cognitive function, and suicidal thoughts and behavior during the month after
hospital discharge, a known high-risk period for suicide.

## Key facts

- **NIH application ID:** 10469693
- **Project number:** 5R01MH125155-03
- **Recipient organization:** NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
- **Principal Investigator:** Michael F Grunebaum
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $575,915
- **Award type:** 5
- **Project period:** 2020-09-16 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10469693

## Citation

> US National Institutes of Health, RePORTER application 10469693, IM Ketamine for rapid reduction of suicidal thoughts in high-risk emergency room patients: a midazolam-controlled trial (5R01MH125155-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10469693. Licensed CC0.

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