IM Ketamine vs Midazolam for Suicidal ER Patients

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Ketamine; Midazolam

Criteria

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.