Clinical trial NCT03502551: ED Treatment of Suicidal Patients With Ketamine Infusion
Official title: ED Treatment of Suicidal Patients With Ketamine Infusion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Suicide
Suicidal Ideation
Keywords: ketamine
suicide
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Suicidal ideation at 24 hours post-infusion
timeFrame: 24 hours post-infusion
measure: Incidence of Discharge to Outpatient vs. Inpatient Facilities
timeFrame: Through ED stay, an average of 53 hours
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 1 week from enrollment.
Secondary outcomes:
measure: Overall MARDS score
timeFrame: 1 hour, 3 days, and 1 week post-infusion
measure: MARDS Suicidal Ideation (MARDS-SI) score
timeFrame: 1 hour, 3 days, and 1 week post-infusion
measure: Scale for Suicide Ideation-5 (SSI5) score
timeFrame: 1 hour, 3 days, and 1 week post-infusion
measure: ED length of stay
timeFrame: Through ED stay, an average of 53 hours
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Aimee Moulin, MD
role: PRINCIPAL_INVESTIGATOR
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