Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
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.
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | 18 Years to 75 Years |
| Enrollment: | 53 (ESTIMATED) |
| Funded by: | U.S. Fed |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Jun 01, 2015 | |
|---|---|---|
| Primary Completion: | Dec 01, 2017 | ESTIMATED |
| Completion Date: | Aug 31, 2020 | |
| Study First Posted: | Jul 08, 2013 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Feb 13, 2015 |
Sponsors / Collaborators
Lead Sponsor:
Brooke Army Medical Center
Responsible Party:
N/A
Location
Participant Groups
-
active arm
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sham arm
-
placebo
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 75 |
| Age Groups: | Adult / Older Adult |
| 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:
* -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
* 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
Primary Outcomes
-
Change in Beck Scale for Suicidal Ideation 2 hours
More Details
| NCT Number: | NCT01892995 |
|---|---|
| Acronym: | LDK-SI |
| Other IDs: | BAMC-385833-1 |
| Study URL: | https://clinicaltrials.gov/study/NCT01892995 |
Last updated: Sep 29, 2023