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

Not Applicable

• Conditions: Suicide
• Interventions: Drug: Ketamine

• Registration Number: NCT01892995
• Lead Sponsor: Brooke Army Medical Center

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 available

Study Timeline

• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-13
• Last Update Posted: 2015-02-16
• Study Start: 2015-06
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Ketamine	placebo
Ketamine	Ketamine	active arm
Diphenhydramine	Ketamine	sham arm

Primary Outcome Measures

Name	Time	Method
Change in Beck Scale for Suicidal Ideation	2 hours

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States