IM Ketamine vs Midazolam for Suicidal ER Patients

Paused · Phase 4

Conditions studied: Depression, Unipolar, Depression, Bipolar, Suicidal Ideation

In brief

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 facts

Study ID

NCT04640636

Run by

New York State Psychiatric Institute

People needed

90

Starts

2021-02-09

Expected to finish

2028-03-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Comprehensive Psychiatric Emergency Department of Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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