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ED Treatment of Suicidal Patients With Ketamine Infusion

Primary Purpose

Suicide, Suicidal Ideation

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring ketamine, suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with Ketamine

Arm Description

In this arm an IV infusion of 0.5 mg/kg of ketamine will be administered over 40 minutes.

Outcomes

Primary Outcome Measures

Suicidal ideation at 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
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]
Patients will be monitored for adverse events during the course of this study.

Secondary Outcome Measures

Overall MARDS score
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
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
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
The investigators will measure the amount of time that patients in this study remain in the ED before being discharged or transferred.

Full Information

First Posted
March 1, 2018
Last Updated
April 29, 2019
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03502551
Brief Title
ED Treatment of Suicidal Patients With Ketamine Infusion
Official Title
ED Treatment of Suicidal Patients With Ketamine Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Trial never received funding.
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation
Keywords
ketamine, suicide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Ketamine
Arm Type
Experimental
Arm Description
In this arm an IV infusion of 0.5 mg/kg of ketamine will be administered over 40 minutes.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Ketamine infusion (0.5 mg/kg) over 40 minutes.
Primary Outcome Measure Information:
Title
Suicidal ideation at 24 hours post-infusion
Description
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.
Time Frame
24 hours post-infusion
Title
Incidence of Discharge to Outpatient vs. Inpatient Facilities
Description
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).
Time Frame
Through ED stay, an average of 53 hours
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Patients will be monitored for adverse events during the course of this study.
Time Frame
1 week from enrollment.
Secondary Outcome Measure Information:
Title
Overall MARDS score
Description
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.
Time Frame
1 hour, 3 days, and 1 week post-infusion
Title
MARDS Suicidal Ideation (MARDS-SI) score
Description
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.
Time Frame
1 hour, 3 days, and 1 week post-infusion
Title
Scale for Suicide Ideation-5 (SSI5) score
Description
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.
Time Frame
1 hour, 3 days, and 1 week post-infusion
Title
ED length of stay
Description
The investigators will measure the amount of time that patients in this study remain in the ED before being discharged or transferred.
Time Frame
Through ED stay, an average of 53 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee Moulin, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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ED Treatment of Suicidal Patients With Ketamine Infusion

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