Back to resultsEffectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department
Primary Purpose
Depression, Depression Severe, Depression Acute
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sodium Chloride 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Ketamine, Depression, Suicidal Ideation, Emergency Department
Eligibility 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
Sites / Locations
- MercyOne Des Moines Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine
Placebo
Arm Description
Ketamine 0.5 mg/kg in 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose.
0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose
Outcomes
Primary Outcome Measures
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.
ED Return Visit
Number of return visits to the emergency department for any psychiatric reason
Secondary Outcome Measures
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.
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.
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.
Length of stay
Length of stay in hospital
Full Information
NCT ID
NCT04266288
First Posted
February 4, 2020
Last Updated
August 31, 2020
Sponsor
MercyOne Des Moines Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04266288
Brief Title
Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department
Official Title
Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MercyOne Des Moines Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depression Severe, Depression Acute, Depression and Suicide, Suicidal Ideation
Keywords
Ketamine, Depression, Suicidal Ideation, Emergency Department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Ketamine 0.5 mg/kg in 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Active drug
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9%
Other Intervention Name(s)
Normal Saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Depression Symptom Response
Description
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.
Time Frame
Baseline, 4 hours
Title
ED Return Visit
Description
Number of return visits to the emergency department for any psychiatric reason
Time Frame
30 days from discharge
Secondary Outcome Measure Information:
Title
Outpatient follow-up
Description
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.
Time Frame
30 days from discharge
Title
Intoxication
Description
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.
Time Frame
Baseline, 2 hours, 4 hours
Title
Changes in Individual Psychiatric Symptoms
Description
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.
Time Frame
Baseline, 4 hours
Title
Length of stay
Description
Length of stay in hospital
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Bress, PharmD
Organizational Affiliation
MercyOne Des Moines Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adnan Iqbal, MD
Organizational Affiliation
MercyOne Des Moines Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MercyOne Des Moines Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department
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