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

Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Depression; Suicidal Ideation; Depression and Suicide; Depression Severe; Depression Acute
• Intervention / Treatment: Drug: Ketamine; Drug: Sodium Chloride 0.9%

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • MercyOne Des Moines Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Ketamine; Active drug; Other Names: Ketalar
Placebo Comparator: Placebo; 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose	Drug: Sodium Chloride 0.9%; Placebo; Other Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4 hours
ED Return Visit	Number of return visits to the emergency department for any psychiatric reason	30 days from discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, 4 hours
Length of stay	Length of stay in hospital	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.

Collaborators and Investigators

• Sponsor: MercyOne Des Moines Medical Center
• Investigators: Principal Investigator: Kathryn Bress, PharmD, MercyOne Des Moines Medical Center; Principal Investigator: Adnan Iqbal, MD, MercyOne Des Moines Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Ketamine; Emergency Department; Suicidal Ideation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Disease Attributes; Self-Injurious Behavior; Depression; Depressive Disorder; Emergencies; Suicide; Suicidal Ideation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: MMC2019-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No