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ED Treatment of Suicidal Patients With Ketamine Infusion

University of California (UC) Davis logo

University of California (UC) Davis

Status and phase

Withdrawn
Phase 2

Conditions

Suicidal Ideation
Suicide

Treatments

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT03502551
1197884

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Treatment with Ketamine
Experimental group
Description:
In this arm an IV infusion of 0.5 mg/kg of ketamine will be administered over 40 minutes.
Treatment:
Drug: Ketamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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