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.

Intervention / Treatment

  • Ketamine (DRUG)
    N/A

Condition or Disease

  • Suicide

Phase

  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 53 (ESTIMATED)
    Funded by: U.S. Fed
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 01, 2015
    Primary Completion: Dec 01, 2017 ESTIMATED
    Completion Date: Aug 31, 2020
    Study First Posted: Jul 08, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Feb 13, 2015

    Sponsors / Collaborators

    Responsible Party: N/A

    Participant Groups

    • active arm

    • sham arm

    • placebo

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Change in Beck Scale for Suicidal Ideation 2 hours

    More Details

    NCT Number: NCT01892995
    Acronym: LDK-SI
    Other IDs: BAMC-385833-1
    Study URL: https://clinicaltrials.gov/study/NCT01892995
    Last updated: Sep 29, 2023