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

NCT ID: NCT06085937

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-04-30

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.

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 reduction of depressive and suicidal symptoms as well as length of stay. Select patients will be given 0.2mg/kg of ketamine IV and observed in the ED for two hours. Vital signs and symptoms will be monitored. Patients will then be transferred to an admitting psychiatric hospital for definitive care as per standard of care. Surveys will be administered at times 0, 2 hours, 24 hours, and 72 hours to assess depressive and suicidal symptoms. ED providers and nursing staff will be asked to complete a short survey assessing ease of use and feasibility for ED administration for this purpose.

Specific aims are as follows:

1. To determine the safety of ketamine as a single IV dose in the ED for acutely suicidal patients.

2. To determine the feasibility of ketamine administration in the ED for the acutely suicidal patient.

3. To determine the impact of ketamine administration on depression and suicidal ideation in the acute phase as measured by the MADRS and C-SSRS.

4. To determine the impact on hospital length of stay calculated from ED arrival until discharge from admitting psychiatric hospital.

Conditions

Suicide; Suicidal Ideation; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine

All patients will receive the experimental drug.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Patients will receive 0.2mg/kg of IV ketamine

Interventions

Ketamine

Patients will receive 0.2mg/kg of IV ketamine

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lindsay Maguire, MD

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Maguire, MD

Assistant Professor of Emergency Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Kansas Strawberry Hill Campus

Kansas City, Kansas, United States

Site Status: NOT_YET_RECRUITING

University of Kansas Medical Center Emergency Department

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsay Maguire, MD

Role: CONTACT

lmaguire@kumc.edu

913-588-3580

Lucas Lemar

Role: CONTACT

llemar@kumc.edu

Facility Contacts

Tyler Kjorvestad, MD

Role: primary

tkjorvestad@kumc.edu

Lindsay Maguire, MD

Role: primary

lmaguire@kumc.edu

8048144509

Other Identifiers

STUDY00150830

Identifier Type: -

Identifier Source: org_study_id