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RECRUITING
NCT05696691
PHASE2/PHASE3

Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-01-06

Completion Date

2026-12-31

Last Updated

2025-04-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Ketamine Hydrochloride

100mg IM ketamine to be administered in conjunction with CRP. The ketamine injection will be administered first. Participants will be observed and have vital signs monitored for the first 45 minutes after administering medication in the ED, observing for immediate reactions. Afterwards, participants will continue to be monitored for potential late-term side effects on the inpatient unit. Ketamine will be given only after initial standard of care (SOC) treatment and screening studies have been initiated.

BEHAVIORAL

Crisis Response Plan

Crisis Response Plan is a brief, empirically-validated, Cognitive-Behavioral Therapy-based one-time therapy, and its administration typically takes 30-60 minutes. It begins with a narrative assessment (allowing patients to "tell their story") and concludes with collaboratively constructed plan that outlines strategies for the patient's self-management of future acute suicidal crises. Patients who engage in CRP are given an index card to keep with them that summarizes the emotional management strategies that they collaboratively generate with the CRP provider.

Locations (1)

University Hospital

San Antonio, Texas, United States