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ED Treatment of Suicidal Patients With Ketamine Infusion

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: NCT03502551
Recruitment Status : Withdrawn (Trial never received funding.)
First Posted : April 18, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE March 1, 2018
First Posted Date  ICMJE April 18, 2018
Last Update Posted Date May 1, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Suicidal ideation at 24 hours post-infusion [ Time Frame: 24 hours post-infusion ]
    Suicidal ideation as measured by the Montgomery-Asberg Depression Scale (MARDS) will be assessed at 24 hours post-infusion of ketamine. The scale is a series of 10 questions each having a possible score of 0-6. Total scores are reported on a scale from 0-60, with lower numbers indicating less depression and higher numbers indicative of increasing depression.
  • Incidence of Discharge to Outpatient vs. Inpatient Facilities [ Time Frame: Through ED stay, an average of 53 hours ]
    The investigators will collect information about what location patients enrolled in this study are discharged to (E.g. home, outpatient crisis residential facility, inpatient psychiatric hospital, admission to general hospital).
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 1 week from enrollment. ]
    Patients will be monitored for adverse events during the course of this study.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Suicidal ideation at 24 hours post-infusion [ Time Frame: 24 hours post-infusion ]
    Suicidal ideation as measured by the Montgomery-Asberg Depression Scale (MARDS) will be assessed at 24 hours post-infusion of ketamine. The scale is a series of 10 questions each having a possible score of 0-6. Total scores are reported on a scale from 0-60, with lower numbers indicating less depression and higher numbers indicative of increasing depression.
  • ED Disposition Location [ Time Frame: Through ED stay, an average of 53 hours ]
    We will collect information about what location patients enrolled in this study are discharged to (E.g. home, outpatient crisis residential facility, inpatient psychiatric hospital, admission to general hospital).
  • Adverse events during first week of enrollment [ Time Frame: 1 week from enrollment. ]
    Patients will be monitored for adverse events during the course of this study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Overall MARDS score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]
    The MARDS will be administered regularly throughout the study and will serve as a measure of suicidal ideation. The scale is a series of 10 questions each having a possible score of 0-6. Total scores are reported on a scale from 0-60, with lower numbers indicating less depression and higher numbers indicative of increasing depression.
  • MARDS Suicidal Ideation (MARDS-SI) score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]
    The MARDS will be administered regularly throughout the study and will serve as a measure of suicidal ideation. Item 10 on the MARDS serves to specifically measure suicidal ideation with a score of 4 or greater being considered to indicate marked suicidal ideations.
  • Scale for Suicide Ideation-5 (SSI5) score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]
    The Scale for Suicide Ideation (SSI) will be administered regularly throughout the study and will serve as a measure of suicidal ideation. Items 1-5 on the SSI serves to specifically measure suicidal ideation. Each of the five questions on the scale have three possible answers with scores ranging from 0 (no suicidal ideation) to 2 (increased suicidal ideation). To compute the SSI5, the scores from each of the five questions are added together to give an overall score from 0-10, where 0 is no suicidal ideation and 10 is increased suicidal ideation.
  • ED length of stay [ Time Frame: Through ED stay, an average of 53 hours ]
    The investigators will measure the amount of time that patients in this study remain in the ED before being discharged or transferred.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Overall MARDS score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]
    The MARDS will be administered regularly throughout the study and will serve as a measure of suicidal ideation. The scale is a series of 10 questions each having a possible score of 0-6. Total scores are reported on a scale from 0-60, with lower numbers indicating less depression and higher numbers indicative of increasing depression.
  • MARDS Suicidal Ideation (MARDS-SI) score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]
    The MARDS will be administered regularly throughout the study and will serve as a measure of suicidal ideation. Item 10 on the MARDS serves to specifically measure suicidal ideation with a score of 4 or greater being considered to indicate marked suicidal ideations.
  • Scale for Suicide Ideation-5 (SSI5) score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]
    The Scale for Suicide Ideation (SSI) will be administered regularly throughout the study and will serve as a measure of suicidal ideation. Items 1-5 on the SSI serves to specifically measure suicidal ideation. Each of the five questions on the scale have three possible answers with scores ranging from 0 (no suicidal ideation) to 2 (increased suicidal ideation). To compute the SSI5, the scores from each of the five questions are added together to give an overall score from 0-10, where 0 is no suicidal ideation and 10 is increased suicidal ideation.
  • ED length of stay [ Time Frame: Through ED stay, an average of 53 hours ]
    We will measure the amount of time that patients in this study remain in the ED before being discharged or transferred.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ED Treatment of Suicidal Patients With Ketamine Infusion
Official Title  ICMJE ED Treatment of Suicidal Patients With Ketamine Infusion
Brief Summary This study aims to determine if a single intravenous (IV) dose of ketamine given in the emergency department (ED) can provide a long term reduction in suicidal ideation, lower time to ED discharge, and increase discharge to home or voluntary treatment facilities all while being safe.
Detailed Description

Suicide has risen to the 2nd leading cause of death in Americans aged 10 to 34, and is the10th leading cause of death overall. Globally, the World Health Organization estimates one person dies of suicide every 40 seconds. Despite its lethality, no recognized acute treatments for suicidality exist. Recently, ketamine, an N-methyl-D-aspartate (NMDA) receptor agonist, has been shown to rapidly reduce suicidality in small studies in psychiatric settings. However, most patients with acute suicidal thoughts are treated initially in Emergency Departments (EDs). Delays in treatment have both short and long term impacts on recovery as patients spend longer time frames in an actively suicidal state.

Identifying a rapid and effective treatment for suicidal ideation that can be administered in the ED would have a profound impact on the emergent management of patients with suicidal thoughts. Ketamine is an FDA approved medication that is commonly used in EDs for multiple indications. EDs have the familiarity, facilities and personnel to safely administer IV ketamine.

Ketamine is regularly used in EDs in high doses for procedural sedation in adults and children. It is also used in high doses as a sedative for acutely agitated patients. In low-doses ketamine is frequently used for its analgesic properties and is considered safe.

Ketamine has also been safely used in the pre-hospital setting. In a recent joint policy statement of the American College of Emergency Physicians recommended the use of low-dose ketamine for pain in control with a safety profile comparable to other intravenous analgesia such as morphine.

Use of Ketamine to rapidly reduce suicidality may facilitate a safe and faster transition of acutely suicidal patients to outpatient treatment. Such treatment potentially shortens these patients' ED and hospital lengths of stay.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Suicide
  • Suicidal Ideation
Intervention  ICMJE Drug: Ketamine
Ketamine infusion (0.5 mg/kg) over 40 minutes.
Other Name: Ketalar
Study Arms  ICMJE Experimental: Treatment with Ketamine
In this arm an IV infusion of 0.5 mg/kg of ketamine will be administered over 40 minutes.
Intervention: Drug: Ketamine
Publications *

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 29, 2019)		 0
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)		 30
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • Chief complaint of suicidal thoughts with a MADRS-SI score > 3
  • Major depressive episode with MADRS > 19 (moderate to severe)

Exclusion Criteria:

  • Pregnancy
  • Psychosis
  • Acute intoxication with alcohol or illicit drugs
  • Acute withdrawal from alcohol or illicit drugs
  • Adults otherwise unable to consent
  • Concurrent, active medical illness requiring medical hospitalization
  • Inability to follow-up including no permanent address or valid telephone number
  • Patients unable to attend outpatient follow-up (no medical insurance, refusal to follow-up, no established care provider)
  • Specific contraindication to the use of ketamine (concern for increased intracranial or intraocular pressure, known allergy to ketamine)
  • Greater than 12 hours from time of ED presentation
  • Prisoners
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 NCT03502551
Other Study ID Numbers  ICMJE 1197884
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of California, Davis
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Davis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aimee Moulin, MD University of California, Davis
PRS Account University of California, Davis
Verification Date April 2019

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