Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Ketamine

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.