Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department (NCT06085937) | Clinical Trial Compass
RecruitingPhase 1
Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department
United States50 participantsStarted 2024-05-01
Plain-language summary
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 participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: 2 hours
2
Provider and Nursing Attitudes toward use of Ketamine for Suicidal Patients in the ED [Feasibility]