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

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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

Tracking Information
First Submitted Date  ICMJE February 4, 2020
First Posted Date  ICMJE February 12, 2020
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE October 18, 2019
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
  • Depression Symptom Response [ Time Frame: Baseline, 4 hours ]
    At least 50% decrease in 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.
  • ED Return Visit [ Time Frame: 30 days from discharge ]
    Number of return visits to the emergency department for any psychiatric reason
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
  • Outpatient follow-up [ Time Frame: 30 days from discharge ]
    Outpatient psychiatric visit, or visit with primary care provider for psychiatric care
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department
Official Title  ICMJE Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Depression Severe
  • Depression Acute
  • Depression and Suicide
  • Suicidal Ideation
Intervention  ICMJE
  • Drug: Ketamine
    Active drug
    Other Name: Ketalar
  • Drug: Sodium Chloride 0.9%
    Placebo
    Other Name: Normal Saline
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose
    Intervention: Drug: Sodium Chloride 0.9%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2020)
29
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2020)
200
Actual Study Completion Date  ICMJE May 31, 2020
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04266288
Other Study ID Numbers  ICMJE MMC2019-46
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kathryn Bress, PharmD, MercyOne Des Moines Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MercyOne Des Moines Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathryn Bress, PharmD MercyOne Des Moines Medical Center
Principal Investigator: Adnan Iqbal, MD MercyOne Des Moines Medical Center
PRS Account MercyOne Des Moines Medical Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP