Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

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.

Conditions

• Suicide

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.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

• Robert De Lorenzo, MD, MSM · UT Health San Antonio

• Romeo Fairley, MD, MPH · UT Health San Antonio

• Alan Peterson, PhD, ABPP · UT Health San Antonio

• Stacey Young-McCaughan, RN, PhD · UT Health San Antonio

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-06

Primary Completion

2026-04-30

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations