Actively Recruiting
Ketamine & Crisis Response Plan for Suicidal Ideation in the ED
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-04-11
24
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting. This study will assess a combination of a pharmacologic intervention and a psychosocial one. The pharmacologic intervention is a one-time dose of 100mg ketamine delivered intramuscularly (IM) while the patient is in the ED. The psychosocial intervention under study is a brief, patient-centered therapy which takes, on average, 30 minutes to administer. Both interventions will be administered only once. The main questions this study aims to answer are: * Determine if 100mg of IM ketamine and Crisis Response Plan in combination results in greater short-term reductions in suicidal ideation in adult patients who report acutely elevated suicide risk during an ED visit. * Examine potential weight-based dose response differences in the reductions in suicidal ideation to determine if future treatment protocols with IM ketamine may benefit from weight-based dosing.
CONDITIONS
Official Title
Ketamine & Crisis Response Plan for Suicidal Ideation in the ED
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation.
- Patient cleared for admission to the University Hospital inpatient psychiatric unit.
- Decision to admit the patient to the inpatient unit or psychiatric stabilization unit made prior to consent.
- Individuals presenting to the ED for other complaints but found to have suicidal ideation necessitating admission.
- Able to read and write English.
You will not qualify if you...
- Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms.
- Acute intoxication with clinically significant symptoms.
- Unable to understand research procedures or provide informed consent.
- Lack of reliable means to be available for follow-up assessments.
- Persistent resting blood pressure lower than 90/60 or higher than 180/110.
- Persistent resting heart rate lower than 45 beats/minute or higher than 120 beats/minute.
- Injuries requiring procedural sedation.
- Pregnancy or breast feeding.
- Known hypersensitivity to ketamine.
- Legal or illegal use of ketamine in the previous 90 days.
- End-stage or severe cardiovascular, liver, or kidney disease.
- Patient is a prisoner.
- Patient is physically restrained or actively under custody of law enforcement.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
S
Stehanie Perez, MHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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