Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03502551

ED Treatment of Suicidal Patients With Ketamine Infusion

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University of California, Davis · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DRUGKetamineKetamine infusion (0.5 mg/kg) over 40 minutes.

Timeline

Start date
2019-04-01
Primary completion
2019-06-30
Completion
2019-06-30
First posted
2018-04-18
Last updated
2019-05-01

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03502551. Inclusion in this directory is not an endorsement.