ED Treatment of Suicidal Patients With Ketamine Infusion
|ClinicalTrials.gov Identifier: NCT03502551|
Recruitment Status : Withdrawn (Trial never received funding.)
First Posted : April 18, 2018
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Suicide Suicidal Ideation||Drug: Ketamine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ED Treatment of Suicidal Patients With Ketamine Infusion|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: Treatment with Ketamine
In this arm an IV infusion of 0.5 mg/kg of ketamine will be administered over 40 minutes.
Ketamine infusion (0.5 mg/kg) over 40 minutes.
Other Name: Ketalar
- Suicidal ideation at 24 hours post-infusion [ Time Frame: 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.
- Incidence of Discharge to Outpatient vs. Inpatient Facilities [ Time Frame: Through ED stay, an average of 53 hours ]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).
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 1 week from enrollment. ]Patients will be monitored for adverse events during the course of this study.
- Overall MARDS score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]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.
- MARDS Suicidal Ideation (MARDS-SI) score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]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.
- Scale for Suicide Ideation-5 (SSI5) score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]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.
- ED length of stay [ Time Frame: Through ED stay, an average of 53 hours ]The investigators will measure the amount of time that patients in this study remain in the ED before being discharged or transferred.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502551
|United States, California|
|University of California Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Aimee Moulin, MD||University of California, Davis|