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Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial (LDK-SI)

Primary Purpose

Suicide

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring suicide, ketamine, low-dose ketamine, suicidal ideations, emergency department

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients age 18 to less than 75 who present to the SAMMC ED with either overt or incidental suicidal ideations with a SADPERSONS score 5 or greater that the treating provider feels warrant formal evaluation.

Exclusion Criteria:

  • -Poor vital sign stability hypoxia: O2 < 95%, hypotension: SBP< 90 hypertension: SBP>180 Heart rate: < 50 or >120 Respiratory Rate: <10 or >30
  • Altered mental status or intoxication
  • Patient is unwilling to participate or provide informed consent
  • Any allergy to ketamine or diphenhydramine
  • Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis
  • Pregnancy or breast feeding
  • Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
  • Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
  • Presence of intracranial mass or vascular lesion.
  • Presence of a history of psychosis or hallucinations (as assessed by electronic chart review)
  • Weight greater than 115 kg or less than 45kg
  • History of increased intracranial pressure/hypertensive hydrocephalus
  • Non-English speaking patients
  • Patient is acutely psychotic
  • Provider feels that patient currently or likely will require chemical and/or physical restraints
  • History of prolonged QT-interval

Sites / Locations

  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Placebo Comparator

Arm Label

Ketamine

Diphenhydramine

Saline

Arm Description

active arm

sham arm

placebo

Outcomes

Primary Outcome Measures

Change in Beck Scale for Suicidal Ideation

Secondary Outcome Measures

Full Information

First Posted
July 2, 2013
Last Updated
February 13, 2015
Sponsor
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01892995
Brief Title
Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
Acronym
LDK-SI
Official Title
Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will enroll patients presenting to the emergency department with acute suicidal ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial measurements will be made in the ED and at follow-up intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
suicide, ketamine, low-dose ketamine, suicidal ideations, emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
active arm
Arm Title
Diphenhydramine
Arm Type
Sham Comparator
Arm Description
sham arm
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Ketamine
Primary Outcome Measure Information:
Title
Change in Beck Scale for Suicidal Ideation
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients age 18 to less than 75 who present to the SAMMC ED with either overt or incidental suicidal ideations with a SADPERSONS score 5 or greater that the treating provider feels warrant formal evaluation. Exclusion Criteria: -Poor vital sign stability hypoxia: O2 < 95%, hypotension: SBP< 90 hypertension: SBP>180 Heart rate: < 50 or >120 Respiratory Rate: <10 or >30 Altered mental status or intoxication Patient is unwilling to participate or provide informed consent Any allergy to ketamine or diphenhydramine Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis Pregnancy or breast feeding Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias Presence of intracranial mass or vascular lesion. Presence of a history of psychosis or hallucinations (as assessed by electronic chart review) Weight greater than 115 kg or less than 45kg History of increased intracranial pressure/hypertensive hydrocephalus Non-English speaking patients Patient is acutely psychotic Provider feels that patient currently or likely will require chemical and/or physical restraints History of prolonged QT-interval
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven G Schauer, DO
Phone
2109160808
Email
sgschauer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn M Varney, DO
Phone
2109160808
Email
shawn.m.varney.mil@mail.mil
Facility Information:
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

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Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial

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