Rapid relief of suicidal thoughts with ketamine and a crisis plan in the emergency department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial enlists adults aged 18–70 who present to the emergency department with acute suicidal ideation and are expected to be admitted. Participants will be randomized to one of four arms receiving ketamine or placebo, with or without a Crisis Response Plan, followed by 1 hour of monitoring for side effects and vital signs. A brief psychological CRP session is delivered by a trained therapist, and safety planning is provided at discharge for control participants. Follow-up assessments will track changes in suicidality while ensuring safety and standard ED care. The goal is to determine if combining ketamine with CRP accelerates reduction in suicidal thoughts prior to inpatient admission.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation anticipated to be admitted as an inpatient at University Health (UH) or Carl R Darnall Army Medical Center (CRDAMC) based on the ED and admitting providers determination that the patient warrants hospitalization for suicidality and the capacity of the institution to admit the patient.
* Able to read and write English.

Exclusion Criteria:

* Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms determined to be the priority of treatment relative to treatment of the suicidal thoughts and behaviors.
* Acute intoxication with clinically significant symptoms as determined by the ED provider to significantly increase the risk of participation (e.g., potential interaction with ketamine) or render the patient unable to consent.
* The patient is not capable of understanding the research procedures and providing informed consent for themselves as determined by the research staff obtaining informed consent in consultation with the patient's ED provider.
* Admittance to and treatment in an ED for acute suicidality within the past 30 days as determined by self-report, or if available, hospital records.
* Lack of reliable means to be available for follow-up assessments (e. g, working mobile phone) as determined by self-report.
* Persistent resting blood pressure lower than 90/60 or higher than 180/110, or persistent resting heart rate lower than 45 beats/minute or higher than 120 beats/minute.
* Injuries requiring procedural sedation with ketamine as determined by the patient's ED provider.
* Pregnancy as determined by pregnancy testing, or self-report of breast feeding.
* Known hypersensitivity to ketamine as determined by self-report.
* Legal or illegal use of ketamine in the previous 90 days as determined by self-report.
* End-stage or severe cardiovascular (e.g., acute coronary syndrome (ACS) or decompensated heart failure), end-stage or severe liver, or kidney disease as determined by the ED chart history and ED provider's exam.
* Patient is a prisoner as determined by prisoner escort.
* Patient is physically restrained or actively under custody of law enforcement.

Where it's running

• University Hospital (UH)
  San Antonio, Texas, United States Recruiting
• Carl R Darnall Army Medical Center (CRDAMC)
  Fort Hood, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Robert DeLorenzo, MD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Robert DeLorenzo, MD
• Email: DeLorenzo@uthscsa.edu
• Phone: 210-567-4786

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.