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OpenTrials
Completed

NCT Number: NCT04266288

Effectiveness of Ketamine for Depression and Suicidal Ideation 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MercyOne Des Moines Medical Center

Des Moines, Iowa, 50314, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Active drug

Other names: Ketalar

Sodium chloride 0.9%

Drug

Placebo

Other names: Normal Saline

Primary outcomes

  1. 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.

  2. ED Return Visit

    Time frame: 30 days from discharge

    Number of return visits to the emergency department for any psychiatric reason

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

MercyOne Des Moines Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2020
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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