Status:
RECRUITING
Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department
Lead Sponsor:
Lindsay Maguire, MD
Conditions:
Suicide
Suicidal Ideation
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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, intraveno...
Detailed Description
In this phase one trial, the investigators' objective is to establish the safety and feasibility of the study dose and route of administration, as well as to provide preliminary data on efficacy in re...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06085937
Start Date
May 1 2024
End Date
April 1 2026
Last Update
July 10 2025
Active Locations (2)
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1
University of Kansas Strawberry Hill Campus
Kansas City, Kansas, United States, 66101
2
University of Kansas Medical Center Emergency Department
Kansas City, Kansas, United States, 66160