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

NCT01892995 | Unknown

• 1 other identifier: BAMC-385833-1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide

Keywords

suicide; ketamine; low-dose ketamine; suicidal ideations; emergency department

Outcome Measures

Primary Outcomes (1)

• Change in Beck Scale for Suicidal Ideation

  2 hours

Study Arms (3)

Ketamine

EXPERIMENTAL

active arm

Drug: Ketamine

Diphenhydramine

SHAM COMPARATOR

sham arm

Drug: Ketamine

Saline

PLACEBO COMPARATOR

placebo

Drug: Ketamine

Interventions

Ketamine DRUG

Diphenhydramine; Ketamine; Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Suicide; Suicidal Ideation; Emergencies

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Steven G Schauer, DO

CONTACT

2109160808; sgschauer@gmail.com

Shawn M Varney, DO

CONTACT

2109160808; shawn.m.varney.mil@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CPT

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 8, 2013
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

US (1)