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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Safety of Single Dose Ketamine for Acutely Suicidal Patients in the Emergency Department

Conditions
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Suicide, Suicidal Ideation, Depression

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>All patients will receive the experimental drug. | Drug: Ketamine<br>* Patients will receive 0.2mg/kg of IV ketamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 72 hours | 
| Hospital Length of Stay | Impact of administration of ketamine on overall psychiatric hospital length of stay. | up to 2 weeks |