Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial

Study Overview
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Brief Summary
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This study will enroll patients presenting to the emergency department with acute suicidal ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial measurements will be made in the ED and at follow-up intervals.

Official Title
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Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial

Conditions
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Suicide

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18 to less than 75 who present to the SAMMC ED with either overt or incidental suicidal ideations with a SADPERSONS score 5 or greater that the treating provider feels warrant formal evaluation. Exclusion Criteria: -Poor vital sign stability hypoxia: O2 < 95%, hypotension: SBP< 90 hypertension: SBP>180 Heart rate: < 50 or >120 Respiratory Rate: <10 or >30 Altered mental status or intoxication Patient is unwilling to participate or provide informed consent Any allergy to ketamine or diphenhydramine Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis Pregnancy or breast feeding Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias Presence of intracranial mass or vascular lesion. Presence of a history of psychosis or hallucinations (as assessed by electronic chart review) Weight greater than 115 kg or less than 45kg History of increased intracranial pressure/hypertensive hydrocephalus Non-English speaking patients Patient is acutely psychotic Provider feels that patient currently or likely will require chemical and/or physical restraints History of prolonged QT-interval

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>active arm | Drug: Ketamine<br> <br> |
| Sham Comparator: Diphenhydramine<br>sham arm | Drug: Ketamine<br> <br> |
| Placebo Comparator: Saline<br>placebo | Drug: Ketamine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beck Scale for Suicidal Ideation |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suicide, ketamine, low-dose ketamine, suicidal ideations, emergency department