Clinical trial NCT04266288: Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department
Official title: Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Depression Severe
Depression Acute
Depression and Suicide
Suicidal Ideation
Keywords: Ketamine
Depression
Suicidal Ideation
Emergency Department
Lead sponsor: MercyOne Des Moines Medical Center
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of a low-dose ketamine infusion on depression symptoms within the Emergency Department (ED) visit, and healthcare utilization after leaving the ED, when administered in the ED for depression or suicidal ideation.

Detailed description: Patients will be identified based on either a chief complaint of suicidal ideation, suicide attempt, or severe depression, or if the patient indicates during intake assessment that they have thoughts of harming or killing their self. Identified patients will be assessed by the ED provider for inclusion and exclusion criteria. If the patient is a candidate for the trial and gives their informed consent for enrollment, they will be randomized to receive either ketamine or placebo by a computer program that maintains blinding. The patient will be assessed by psychiatry for disposition and treatment plan prior to receiving the study drug, and will be reassessed four hours after the infusion. Thirty days after the patient leaves the hospital (either leaves from the ED or is discharged from inpatient admission), they will be contacted to follow up on their healthcare utilization after discharge.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age and older
* Presenting to the ED with a chief complaint of severe depression or suicidality, or presenting to the ED with any other chief complaint but answering "yes" to "Thoughts of harming/killing yourself?" during intake/triage

Exclusion Criteria:

* Acute mania or psychosis
* Enrollment in trial during a prior emergency department visit
* History of ketamine abuse or dependence
* Known hypersensitivity to ketamine
* Acute intoxication with any drug of abuse (including alcohol)
* Pregnancy or lactation
* Any condition that would place the patient at serious risk of harm from an increase in blood pressure (e.g. history of intracerebral hemorrhage, aneurysmal vascular disease, or arteriovenous malformation)
* Assessing provider does not want to enroll patient for any other reason, based on their clinical judgement

Primary outcomes:
measure: Depression Symptom Response
timeFrame: Baseline, 4 hours
measure: ED Return Visit
timeFrame: 30 days from discharge
Secondary outcomes:
measure: Outpatient follow-up
timeFrame: 30 days from discharge
measure: Intoxication
timeFrame: Baseline, 2 hours, 4 hours
measure: Changes in Individual Psychiatric Symptoms
timeFrame: Baseline, 4 hours
measure: Length of stay
timeFrame: Time from arrival in ED to discharge, either directly from the ED or after inpatient admission. Average length of stay is less than 14 days.
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: MercyOne Des Moines Medical Center
state: Iowa
Study officials:
affiliation: MercyOne Des Moines Medical Center
name: Kathryn Bress, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: MercyOne Des Moines Medical Center
name: Adnan Iqbal, MD
role: PRINCIPAL_INVESTIGATOR
References: