Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

Suicide Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study is a phase II/III Clinical Pilot Trial. The study participants will be randomized to one of two groups: IM ketamine plus Crisis Response Planning (intervention group) or usual care (control group). Prior to treatment, we will obtain demographic and contact information for patients and for a friend/family member as a collateral reporter of symptom change and safety. As part of informed consent, participants will be warned about the potential for temporary effects of ketamine and provided an enrollment card to inform other care providers of their participation in a ketamine study. Participants will be weighed and complete a series of brief survey assessments. Clinical assessments such as history, physical examination, and routine laboratory testing will be collected as part of usual care. Ketamine and Crisis Response Planning will be administered, and study assessments will be repeated at 120 minutes posttreatment. To ensure the highest level of patient safety, we are proposing only to include patients who have already been cleared for a psychiatric hospitalization. This will also allow for close monitoring of symptom changes during the initial hours and days following treatment. Outcome measures will be collected at two hours, 3 days, and 1 month after the intervention. Research staff will collect assessments by telephone interview and/or visits. Consistent with established protocols, staff will be trained and supervised by STRONG STAR mental health professionals with expertise in evidence-based processes for assessing and responding to suicide risk. Trained and experienced therapists are available to meet with participants to develop a Crisis Response Plan at University Hospital. ;

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide

• NCT number: NCT05696691
• Study type: Interventional
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Stehanie Perez, MHA
• Phone: 2104508973
• Email: perezs11@uthscsa.edu
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 6, 2023
• Completion date: December 2026