Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department

Overview

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.

Full Title of Study: “Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2020

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.

Interventions

  • Drug: Ketamine
    • Active drug
  • Drug: Sodium Chloride 0.9%
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Ketamine
    • Ketamine 0.5 mg/kg in 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose.
  • Placebo Comparator: Placebo
    • 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose

Clinical Trial Outcome Measures

Primary Measures

  • Depression Symptom Response
    • Time Frame: Baseline, 4 hours
    • 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.
  • ED Return Visit
    • Time Frame: 30 days from discharge
    • Number of return visits to the emergency department for any psychiatric reason

Secondary Measures

  • Outpatient follow-up
    • Time Frame: 30 days from discharge
    • 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.
  • Intoxication
    • Time Frame: Baseline, 2 hours, 4 hours
    • 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.
  • Changes in Individual Psychiatric Symptoms
    • Time Frame: Baseline, 4 hours
    • 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.
  • Length of stay
    • 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.
    • Length of stay in hospital

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MercyOne Des Moines Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kathryn Bress, PharmD, Pharmacist – MercyOne Des Moines Medical Center
  • Overall Official(s)
    • Kathryn Bress, PharmD, Principal Investigator, MercyOne Des Moines Medical Center
    • Adnan Iqbal, MD, Principal Investigator, MercyOne Des Moines Medical Center

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