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

Suicide Clinical Trial

— LDK-SI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01892995
• Other study ID #: BAMC-385833-1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 2, 2013
• Last updated: February 13, 2015
• Start date: June 2015

Study information

• Verified date: February 2015
• Source: Brooke Army Medical Center
• Contact: Steven G Schauer, DO
• Phone: 2109160808
• Email: sgschauer[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT02367586

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 53
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Suicidal Ideation
• Suicide

Intervention

Drug:
• Ketamine

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Beck Scale for Suicidal Ideation		2 hours	No