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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2017

Interventions

  • Drug: Ketamine

Arms, Groups and Cohorts

  • Experimental: Ketamine
    • active arm
  • Sham Comparator: Diphenhydramine
    • sham arm
  • Placebo Comparator: Saline
    • placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change in Beck Scale for Suicidal Ideation
    • Time Frame: 2 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brooke Army Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steven Schauer, CPT – Brooke Army Medical Center
  • Overall Contact(s)
    • Steven G Schauer, DO, 2109160808, sgschauer@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.