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

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: NCT01892995
Recruitment Status : Unknown
Verified February 2015 by Steven Schauer, Brooke Army Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 8, 2013
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Steven Schauer, Brooke Army Medical Center

Tracking Information
First Submitted Date  ICMJE July 2, 2013
First Posted Date  ICMJE July 8, 2013
Last Update Posted Date February 16, 2015
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Change in Beck Scale for Suicidal Ideation [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
Official Title  ICMJE Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Suicide
Intervention  ICMJE Drug: Ketamine
Study Arms  ICMJE
  • Experimental: Ketamine
    active arm
    Intervention: Drug: Ketamine
  • Sham Comparator: Diphenhydramine
    sham arm
    Intervention: Drug: Ketamine
  • Placebo Comparator: Saline
    placebo
    Intervention: Drug: Ketamine
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
53
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01892995
Other Study ID Numbers  ICMJE BAMC-385833-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Schauer, Brooke Army Medical Center
Study Sponsor  ICMJE Brooke Army Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brooke Army Medical Center
Verification Date February 2015

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