SuspendedPhase 4

IM Ketamine vs Midazolam for Suicidal ER Patients

NCT04640636 · New York State Psychiatric Institute

Closed to entry

Status

Not accepting participants

Phase 4

Phase

Target enrolment

Study sites

1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Scale for Suicidal Ideation (SSI)
Measured over 24 hours post-treatment

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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.

Where

1 study site

Facility	City	Region	Country
Comprehensive Psychiatric Emergency Department of Columbia University Medical Center	New York	New York	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04640636 on ClinicalTrials.gov →

Last updated in the registry 2026-05-26. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

Recruiting in

New York107

All 12 trials from New York State Psychiatric Institute →