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

Primary Purpose

Suicide, Suicidal Ideation, Depression

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acutely Suicidal (passive or active) GCS 15 Exclusion Criteria: History of psychosis Clinical intoxication Hypertension (SBP > 180 or DBP > 100) Hypotension (SBP < 90) Pregnancy Imprisonment or inability to consent Allergy, intolerance, or previous adverse reaction to ketamine The treating physician determines that the patient is not a good candidate for the study Acute medical condition requiring admission to a medical service Involuntary status

Sites / Locations

  • University of Kansas Strawberry Hill Campus
  • University of Kansas Medical Center Emergency Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketamine

Arm Description

All patients will receive the experimental drug.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Suicidal Ideation
Reduction of SI in ED patients after ketamine administration, as measured by the Columbia Suicide Severity Rating Scale (ideation subscore range 1-5, with higher number indicating increasing suicidal ideation; intensity subscore rating 2-25, with higher number indicating greater severity of suicidal ideation) and Montgomery-Asberg Depression Rating Scale.
Hospital Length of Stay
Impact of administration of ketamine on overall psychiatric hospital length of stay.

Full Information

First Posted
October 2, 2023
Last Updated
October 10, 2023
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06085937
Brief Title
Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department
Official Title
Feasibility and Safety of Single Dose Ketamine for Acutely Suicidal Patients in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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: To determine the safety of ketamine as a single IV dose in the ED for acutely suicidal patients. To determine the feasibility of ketamine administration in the ED for the acutely suicidal patient. To determine the impact of ketamine administration on depression and suicidal ideation in the acute phase as measured by the MADRS and C-SSRS. To determine the impact on hospital length of stay calculated from ED arrival until discharge from admitting psychiatric hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
All patients will receive the experimental drug.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Patients will receive 0.2mg/kg of IV ketamine
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Safety of use of ketamine for SI in the ED, as assessed by number and severity of reported serious adverse outcomes.
Time Frame
2 hours
Title
Provider and Nursing Attitudes toward use of Ketamine for Suicidal Patients in the ED [Feasibility]
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Change in Suicidal Ideation
Description
Reduction of SI in ED patients after ketamine administration, as measured by the Columbia Suicide Severity Rating Scale (ideation subscore range 1-5, with higher number indicating increasing suicidal ideation; intensity subscore rating 2-25, with higher number indicating greater severity of suicidal ideation) and Montgomery-Asberg Depression Rating Scale.
Time Frame
72 hours
Title
Hospital Length of Stay
Description
Impact of administration of ketamine on overall psychiatric hospital length of stay.
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acutely Suicidal (passive or active) GCS 15 Exclusion Criteria: History of psychosis Clinical intoxication Hypertension (SBP > 180 or DBP > 100) Hypotension (SBP < 90) Pregnancy Imprisonment or inability to consent Allergy, intolerance, or previous adverse reaction to ketamine The treating physician determines that the patient is not a good candidate for the study Acute medical condition requiring admission to a medical service Involuntary status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Maguire, MD
Phone
913-588-3580
Email
lmaguire@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas Lemar
Email
llemar@kumc.edu
Facility Information:
Facility Name
University of Kansas Strawberry Hill Campus
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66101
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hanson, MD
Email
jhanson5@kumc.edu
Facility Name
University of Kansas Medical Center Emergency Department
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Maguire, MD
Phone
804-814-4509
Email
lamaguire93@gmail.com

12. IPD Sharing Statement

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

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