Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of a low-dose ketamine infusion on depression symptoms within the Emergency Department (ED) visit, and healthcare utilization after leaving the ED, when administered in the ED for depression or suicidal ideation.

Detailed Description
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Patients will be identified based on either a chief complaint of suicidal ideation, suicide attempt, or severe depression, or if the patient indicates during intake assessment that they have thoughts of harming or killing their self. Identified patients will be assessed by the ED provider for inclusion and exclusion criteria. If the patient is a candidate for the trial and gives their informed consent for enrollment, they will be randomized to receive either ketamine or placebo by a computer program that maintains blinding. The patient will be assessed by psychiatry for disposition and treatment plan prior to receiving the study drug, and will be reassessed four hours after the infusion. Thirty days after the patient leaves the hospital (either leaves from the ED or is discharged from inpatient admission), they will be contacted to follow up on their healthcare utilization after discharge.

Official Title
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Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department

Conditions
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Depression, Depression Severe, Depression Acute, Depression and Suicide, Suicidal Ideation

Intervention / Treatment
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* Drug: Ketamine
* Drug: Sodium Chloride 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years of age and older Presenting to the ED with a chief complaint of severe depression or suicidality, or presenting to the ED with any other chief complaint but answering yes to Thoughts of harming/killing yourself? during intake/triage Exclusion Criteria: Acute mania or psychosis Enrollment in trial during a prior emergency department visit History of ketamine abuse or dependence Known hypersensitivity to ketamine Acute intoxication with any drug of abuse (including alcohol) Pregnancy or lactation Any condition that would place the patient at serious risk of harm from an increase in blood pressure (e.g. history of intracerebral hemorrhage, aneurysmal vascular disease, or arteriovenous malformation) Assessing provider does not want to enroll patient for any other reason, based on their clinical judgement

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>Ketamine 0.5 mg/kg in 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose. | Drug: Ketamine<br>* Active drug<br>* Other names: Ketalar;|
| Placebo Comparator: Placebo<br>0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose | Drug: Sodium Chloride 0.9%<br>* Placebo<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Symptom Response | Patients will be classified as a responder or non-responder, with a response defined as a decrease by 50% or greater for the combined depressive symptom scores of the Brief Psychiatric Rating Scale (BPRS), which includes the following domains: emotional withdrawal, guilt feelings, depressed mood, blunted affect, feelings of inferiority, and suicidal ideation. The total depressive symptom score ranges from 6-42, with a higher score indicating a higher level of severity. Response rate will be compared between the treatment and placebo groups. | Baseline, 4 hours | 
| ED Return Visit | Number of return visits to the emergency department for any psychiatric reason | 30 days from discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outpatient follow-up | Patients will be contacted at 30 days from discharge to obtain outpatient follow-up data. The two results for this outcome are yes or no to having at least one outpatient visit, either with a psychiatry provider or with a primary care provider to obtain psychiatric care. The number of outpatient visits an individual patient reports, if greater than one, does not affect this outcome. Attempts will be made to confirm each reported visit with the provider to minimize the potential for subject bias. | 30 days from discharge | 
| Intoxication | Change in Visual Analog Scale for Intoxication (VAS-High), which ranges from 0 to 8, with a higher score indicating a greater level of impairment. | Baseline, 2 hours, 4 hours | 
| Changes in Individual Psychiatric Symptoms | Change in Brief Psychiatric Rating Scale (BPRS) individual symptom scores, with each range from 1-7, with a higher score indicating a higher level of severity. There are 18 total symptoms evaluated on the BPRS. | Baseline, 4 hours | 
| Length of stay | Length of stay in hospital | Time from arrival in ED to discharge, either directly from the ED or after inpatient admission. Average length of stay is less than 14 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Depression, Suicidal Ideation, Emergency Department