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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
Active drug
Placebo
MercyOne Des Moines Medical Center
Des Moines, Iowa, United States
Depression Symptom Response
Patients will be classified as a responder or non-responder, with a response defined as a decrease by 50% or greater for the combined depressive symptom scores of the Brief Psychiatric Rating Scale (BPRS), which includes the following domains: emotional withdrawal, guilt feelings, depressed mood, blunted affect, feelings of inferiority, and suicidal ideation. The total depressive symptom score ranges from 6-42, with a higher score indicating a higher level of severity. Response rate will be compared between the treatment and placebo groups.
Time frame: Baseline, 4 hours
ED Return Visit
Number of return visits to the emergency department for any psychiatric reason
Time frame: 30 days from discharge
Outpatient follow-up
Patients will be contacted at 30 days from discharge to obtain outpatient follow-up data. The two results for this outcome are "yes" or "no" to having at least one outpatient visit, either with a psychiatry provider or with a primary care provider to obtain psychiatric care. The number of outpatient visits an individual patient reports, if greater than one, does not affect this outcome. Attempts will be made to confirm each reported visit with the provider to minimize the potential for subject bias.
Time frame: 30 days from discharge
Intoxication
Change in Visual Analog Scale for Intoxication (VAS-High), which ranges from 0 to 8, with a higher score indicating a greater level of impairment.
Time frame: Baseline, 2 hours, 4 hours
Changes in Individual Psychiatric Symptoms
Change in Brief Psychiatric Rating Scale (BPRS) individual symptom scores, with each range from 1-7, with a higher score indicating a higher level of severity. There are 18 total symptoms evaluated on the BPRS.
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Time frame: Baseline, 4 hours
Length of stay
Length of stay in hospital
Time frame: 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.