ED Treatment of Suicidal Patients With Ketamine Infusion

Study Overview
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Brief Summary
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This study aims to determine if a single intravenous (IV) dose of ketamine given in the emergency department (ED) can provide a long term reduction in suicidal ideation, lower time to ED discharge, and increase discharge to home or voluntary treatment facilities all while being safe.

Detailed Description
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Suicide has risen to the 2nd leading cause of death in Americans aged 10 to 34, and is the10th leading cause of death overall. Globally, the World Health Organization estimates one person dies of suicide every 40 seconds. Despite its lethality, no recognized acute treatments for suicidality exist. Recently, ketamine, an N-methyl-D-aspartate (NMDA) receptor agonist, has been shown to rapidly reduce suicidality in small studies in psychiatric settings. However, most patients with acute suicidal thoughts are treated initially in Emergency Departments (EDs). Delays in treatment have both short and long term impacts on recovery as patients spend longer time frames in an actively suicidal state. Identifying a rapid and effective treatment for suicidal ideation that can be administered in the ED would have a profound impact on the emergent management of patients with suicidal thoughts. Ketamine is an FDA approved medication that is commonly used in EDs for multiple indications. EDs have the familiarity, facilities and personnel to safely administer IV ketamine. Ketamine is regularly used in EDs in high doses for procedural sedation in adults and children. It is also used in high doses as a sedative for acutely agitated patients. In low-doses ketamine is frequently used for its analgesic properties and is considered safe. Ketamine has also been safely used in the pre-hospital setting. In a recent joint policy statement of the American College of Emergency Physicians recommended the use of low-dose ketamine for pain in control with a safety profile comparable to other intravenous analgesia such as morphine. Use of Ketamine to rapidly reduce suicidality may facilitate a safe and faster transition of acutely suicidal patients to outpatient treatment. Such treatment potentially shortens these patients' ED and hospital lengths of stay.

Official Title
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ED Treatment of Suicidal Patients With Ketamine Infusion

Conditions
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Suicide, Suicidal Ideation

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Chief complaint of suicidal thoughts with a MADRS-SI score > 3 Major depressive episode with MADRS > 19 (moderate to severe) Exclusion Criteria: Pregnancy Psychosis Acute intoxication with alcohol or illicit drugs Acute withdrawal from alcohol or illicit drugs Adults otherwise unable to consent Concurrent, active medical illness requiring medical hospitalization Inability to follow-up including no permanent address or valid telephone number Patients unable to attend outpatient follow-up (no medical insurance, refusal to follow-up, no established care provider) Specific contraindication to the use of ketamine (concern for increased intracranial or intraocular pressure, known allergy to ketamine) Greater than 12 hours from time of ED presentation Prisoners

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Ketamine<br>In this arm an IV infusion of 0.5 mg/kg of ketamine will be administered over 40 minutes. | Drug: Ketamine<br>* Ketamine infusion (0.5 mg/kg) over 40 minutes.<br>* Other names: Ketalar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal ideation at 24 hours post-infusion | Suicidal ideation as measured by the Montgomery-Asberg Depression Scale (MARDS) will be assessed at 24 hours post-infusion of ketamine. The scale is a series of 10 questions each having a possible score of 0-6. Total scores are reported on a scale from 0-60, with lower numbers indicating less depression and higher numbers indicative of increasing depression. | 24 hours post-infusion | 
| Incidence of Discharge to Outpatient vs. Inpatient Facilities | The investigators will collect information about what location patients enrolled in this study are discharged to (E.g. home, outpatient crisis residential facility, inpatient psychiatric hospital, admission to general hospital). | Through ED stay, an average of 53 hours | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Patients will be monitored for adverse events during the course of this study. | 1 week from enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall MARDS score | The MARDS will be administered regularly throughout the study and will serve as a measure of suicidal ideation. The scale is a series of 10 questions each having a possible score of 0-6. Total scores are reported on a scale from 0-60, with lower numbers indicating less depression and higher numbers indicative of increasing depression. | 1 hour, 3 days, and 1 week post-infusion | 
| MARDS Suicidal Ideation (MARDS-SI) score | The MARDS will be administered regularly throughout the study and will serve as a measure of suicidal ideation. Item 10 on the MARDS serves to specifically measure suicidal ideation with a score of 4 or greater being considered to indicate marked suicidal ideations. | 1 hour, 3 days, and 1 week post-infusion | 
| Scale for Suicide Ideation-5 (SSI5) score | The Scale for Suicide Ideation (SSI) will be administered regularly throughout the study and will serve as a measure of suicidal ideation. Items 1-5 on the SSI serves to specifically measure suicidal ideation. Each of the five questions on the scale have three possible answers with scores ranging from 0 (no suicidal ideation) to 2 (increased suicidal ideation). To compute the SSI5, the scores from each of the five questions are added together to give an overall score from 0-10, where 0 is no suicidal ideation and 10 is increased suicidal ideation. | 1 hour, 3 days, and 1 week post-infusion | 
| ED length of stay | The investigators will measure the amount of time that patients in this study remain in the ED before being discharged or transferred. | Through ED stay, an average of 53 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, suicide