Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department
Recruiting · NCT06085937 · Interventional (participants receive a specific treatment) · Lead sponsor: Lindsay Maguire, MD
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
There is currently no readily available pharmacologic intervention for suicidal ideation, a true psychiatric emergency, in the Emergency Department (ED). Investigators aim to trial low-dose, intravenous ketamine, a drug with well-established use in treatment-resistant depression, for patients who present to the ED with suicidal ideation.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Acutely Suicidality ("yes" answer to any of items 4 or 5 on C-SSRS "Suicidal Ideation" category)
- Require inpatient stabilization for SI or actions based on clinical observation and interview
- Are accepted for psychiatric stabilization at the University of Kansas Medical Center's Strawberry Hill campus
- Have a Glasgow Coma Score (GCS) of 15
- Age 18-65
Exclusion criteria
- Current or past history of psychosis
- Current or recent (past 4 weeks) symptoms of mania/hypomania as defined by Young Mania Rating Scale (YRMS) score of 12 or greater
- History of ketamine use disorder
- History of liver transplant
- Pregnancy or breastfeeding
- Imprisonment or inability to consent
- Positive urine drug screen or serum alcohol level
- Hypertension (SBP \> 160 or DBP \> 100 before administration of ketamine)
- Hypotension (SBP \< 90)
- Presence of acute medical condition requiring admission to medical service
- Allergy, intolerance, or previous adverse reaction to ketamine
- Patient has 8+ lifetime ketamine exposures
- The treating physician determines that the patient is not a good candidate for the study (e.g. medical condition/procedure, medication that would contradindicate ketamine treatment)
Where it is running
2 locations listed across 1 US state.
- University of Kansas Strawberry Hill Campus - Kansas City, Kansas, United States
- University of Kansas Medical Center Emergency Department - Kansas City, Kansas, United States