NCT04640636SuspendedPhase 4
IM Ketamine vs Midazolam for Suicidal ER Patients
Source: ClinicalTrials.gov · Last updated 26 May 2026
Reason given: 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.
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 20 Nov 2020
- Start date
- 9 Feb 2021
- Primary completion date
- Sept 2027
- Lead sponsor
- New York State Psychiatric Institute
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT04640636
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Substance use disorder in past 2 weeks
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Comprehensive Psychiatric Emergency Department of Columbia University Medical Center | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.