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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266288
Recruitment Status : Completed
First Posted : February 12, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Kathryn Bress, PharmD, MercyOne Des Moines Medical Center

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.

Condition or disease Intervention/treatment Phase
Depression Depression Severe Depression Acute Depression and Suicide Suicidal Ideation Drug: Ketamine Drug: Sodium Chloride 0.9% Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department
Actual Study Start Date : October 18, 2019
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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 Name: 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 Name: Normal Saline




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266288


Locations
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United States, Iowa
MercyOne Des Moines Medical Center
Des Moines, Iowa, United States, 50314
Sponsors and Collaborators
MercyOne Des Moines Medical Center
Investigators
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Principal Investigator: Kathryn Bress, PharmD MercyOne Des Moines Medical Center
Principal Investigator: Adnan Iqbal, MD MercyOne Des Moines Medical Center
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Responsible Party: Kathryn Bress, PharmD, Pharmacist, MercyOne Des Moines Medical Center
ClinicalTrials.gov Identifier: NCT04266288    
Other Study ID Numbers: MMC2019-46
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathryn Bress, PharmD, MercyOne Des Moines Medical Center:
Ketamine
Depression
Suicidal Ideation
Emergency Department
Additional relevant MeSH terms:
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Emergencies
Depression
Depressive Disorder
Suicide
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Self-Injurious Behavior
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action