Using ketamine and a crisis response plan to help suicidal patients in the emergency department

A Randomized Pilot Trial of Intramuscular Ketamine and Crisis Response Planning for Suicide Prevention in the Emergency Department

This study is testing whether a single dose of ketamine along with a crisis response plan can help adults in the emergency department who are having suicidal thoughts feel better compared to regular care.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (other)
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT05696691 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a one-time intramuscular dose of 100mg ketamine combined with a brief psychosocial intervention known as the Crisis Response Plan for adults experiencing acute suicidal ideation in the emergency department. Participants will be randomly assigned to receive either the combination treatment or usual care. The study will assess changes in suicidal thoughts and overall safety through various follow-up assessments conducted at two hours, three days, and one month post-treatment. The trial will include patients who have been cleared for psychiatric hospitalization to ensure close monitoring and safety during the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who present to the emergency department with acute suicidal ideation and have been cleared for psychiatric hospitalization.

Not a fit: Patients with serious mental illnesses exhibiting active psychosis or acute intoxication may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce suicidal thoughts in patients presenting with acute suicidality.

How similar studies have performed: Previous studies have shown promise in using ketamine for treating acute suicidality, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

* 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 to prevent study procedures from complicating or influencing the disposition and treatment as usual for suicidal patients reporting to the ED.
* Individuals presenting to the ED for other complaints but found to have suicidal ideation necessitating admission will also be eligible.
* 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.
* Acute intoxication with clinically significant symptoms (as defined by the attending clinician's assessment of patients' clinical sobriety).
* The patient is not capable of understanding the research procedures and providing informed consent for themselves.
* Lack of reliable means to be available for follow-up assessments (e.g, working mobile phone).
* 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.
* Pregnancy or breast feeding.
* Known hypersensitivity to ketamine.
* Legal or illegal use of ketamine in the previous 90 days.
* End-stage or severe cardiovascular (e.g., ACS or decompensated heart failure), liver, or kidney disease.
* Patient is a prisoner.
* Patient is physically restrained or actively under custody of law enforcement. Once a patient is no longer under custody of law enforcement or physically restrained, the patient may be considered eligible and may consent to voluntary enrollment in the study.

Where this trial is running

San Antonio, Texas

• University Hospital — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Robert De Lorenzo, MD, MSM — The University of Texas Health Science Center at San Antonio
• Study coordinator: Stehanie Perez, MHA

Conditions: Suicide, Ketamine, Crisis Response Plan, Suicidal Ideation, Emergency Department, Acute Suicidality, Intramuscular Ketamine, Emergency Room