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History of Changes for Study: NCT04266288
Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department
Latest version (submitted January 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 11, 2020 None (earliest Version on record)
2 February 11, 2020 Outcome Measures and Study Status
3 August 31, 2020 Recruitment Status, Study Status and Study Design
4 January 2, 2022
Quality Control Review has not concluded Returned: January 31, 2022
Study Status, Outcome Measures, Document Section and Results
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Study NCT04266288
Submitted Date:  February 11, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: MMC2019-46
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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2020
Overall Status: Enrolling by invitation
Study Start: October 18, 2019
Primary Completion: April 30, 2020 [Anticipated]
Study Completion: May 31, 2020 [Anticipated]
First Submitted: February 4, 2020
First Submitted that
Met QC Criteria:
February 11, 2020
First Posted: February 12, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
February 11, 2020
Last Update Posted: February 12, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: MercyOne Des Moines Medical Center
Responsible Party: Principal Investigator
Investigator: Kathryn Bress, PharmD
Official Title: Pharmacist
Affiliation: MercyOne Des Moines Medical Center
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Open or close this module Conditions
Conditions: Depression
Depression Severe
Depression Acute
Depression and Suicide
Suicidal Ideation
Keywords: Ketamine
Depression
Suicidal Ideation
Emergency Department
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
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 ]

Outpatient psychiatric visit, or visit with primary care provider for psychiatric care
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Kathryn Bress, PharmD
Principal Investigator
MercyOne Des Moines Medical Center
Adnan Iqbal, MD
Principal Investigator
MercyOne Des Moines Medical Center
Locations: United States, Iowa
MercyOne Des Moines Medical Center
Des Moines, Iowa, United States, 50314
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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