Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department

NCT06085937 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00150830
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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, intravenous ketamine, a drug with well-established use in treatment-resistant depression, for patients who present to the ED with suicidal ideation.

Conditions

Suicide; Suicidal Ideation; Depression

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Safety of use of ketamine for SI in the ED, as assessed by number and severity of reported serious adverse outcomes.

  2 hours

• Provider and Nursing Attitudes toward use of Ketamine for Suicidal Patients in the ED [Feasibility]

  A questionnaire will be given to providers and nursing staff to assess \[1\] perceived safety, \[2\] provider comfort, \[3\] perceived efficacy, and \[4\] perceived feasibility for ED use as rated on a Likert scale from 1-5, with 5 relaying best perceived outcomes.

  2 hours

Secondary Outcomes (2)

• Change in Suicidal Ideation

  72 hours

• Hospital Length of Stay

  up to 2 weeks

Study Arms (1)

Ketamine

EXPERIMENTAL

All patients will receive the experimental drug.

Drug: Ketamine

Interventions

Ketamine DRUG

Patients will receive 0.2mg/kg of IV ketamine

Ketamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lindsay Maguire, MD: lead

Study Sites (2)

University of Kansas Strawberry Hill Campus

Kansas City, Kansas, 66101, United States

NOT YET RECRUITING

University of Kansas Medical Center Emergency Department

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Suicidal Ideation; Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Lindsay Maguire, MD

CONTACT

913-588-3580; lmaguire@kumc.edu

Lucas Lemar

CONTACT

llemar@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 17, 2023
• Study Start: May 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (2)