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Status unknownNCT01892995LDK-SIUpdated Feb 16, 2015

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

An interventional study of Ketamine in Suicide, sponsored by Brooke Army Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-16.

Sponsored by Brooke Army Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Suicide

Keywords

  • suicide
  • ketamine
  • low-dose ketamine
  • suicidal ideations
  • emergency department
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's planned enrollment of 53 is below the median of 145 across 931 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Brooke Army Medical Center is the lead sponsor of 92 studies on the registry; 11 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
53 participants (estimated)

Study arms

  • Experimental
    Ketamine

    active arm

    Drug: Ketamine

  • Sham comparator
    Diphenhydramine

    sham arm

    Drug: Ketamine

  • Placebo comparator
    Saline

    placebo

    Drug: Ketamine

Interventions

  • DrugKetamine
06

What researchers measure

Primary outcomes

  1. Change in Beck Scale for Suicidal Ideation

    Time frame: 2 hours

07

Study locations

1 site
  • Brooke Army Medical Center
    Fort Sam Houston, Texas 78234, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01892995
Lead sponsor
Brooke Army Medical Center
Responsible party
Steven Schauer (CPT, Brooke Army Medical Center) — Principal investigator
First posted
Jul 8, 2013
Start date
Jun 2015
Primary completion
Dec 2017 (estimated)
Last update
Feb 16, 2015

Study contacts

Steven G Schauer, DO
Contact
sgschauer@gmail.com
2109160808
Shawn M Varney, DO
Contact
shawn.m.varney.mil@mail.mil
2109160808

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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