Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide
• Intervention / Treatment: Drug: Ketamine Hydrochloride; Behavioral: Crisis Response Plan

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Stehanie Perez, MHA; Phone Number: 2104508973; Email: perezs11@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University Hospital
      • Contact: Robert DeLorenzo, MD; Phone Number: 210-567-4292; Email: delorenzo@uthscsa.edu
      • Principal Investigator: Robert A De Lorenzo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamine and Crisis Response Plan (CRP); Individuals randomized to the experimental arm will receive 100mg intramuscular ketamine injection before completing the Crisis Response Plan. The average timeframe for the experimental arm is anticipated to be approximately 60 minutes of active treatment. Following ketamine administration, the subject will be monitored for 45 minutes with pulse oximetry and recurrent vital signs. The study team will record when the CRP is completed in relation to the ketamine injection.	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.; Other Names: Ketamine; 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.; Other Names: CRP
No Intervention: Treatment as Usual; Individuals randomized to the no intervention arm will receive routine care from emergency providers and psychiatry staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study interventions	Number of enrolled subjects completing treatment within study parameters, with safety and side-effect profiles at or lower than published rates.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Beck Scale for Suicidal Ideation (SSI) Score	The Beck Scale for Suicidal Ideation (SSI) is a 21-item measurement that evaluates the presence and intensity of suicidal thoughts. Each item is scored on a scale from 0-2 with a total score of 0-38; with higher scores indicating higher levels of suicidal ideation.	Baseline to 30 days
Change in Depressive Symptoms Index-Suicidality Subscale (DSI-SS) Score	The Depressive Symptoms Index-Suicidality Subscale (DSI-SS) is a 4-item measure of suicidal ideation. Respondents rate each item on a 4-point scale ranging from 0-3. Responses are summed, and higher scores reflect more severe suicidal ideation (range: 0-12).	Baseline to 30 days
Change in Suicide Visual Analog Scale (S-VAS) Score	The Suicide Visual Analog Scale is a 1-item momentary assessment to evaluate severity of suicidal ideation. The item is scored from 0-100 and the total possible score range for the scale is therefore also 0-100. Lower scores indicate less extreme current urges toward self harm, whereas higher scores are indicative of more severe urges.	Baseline to 30 days

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Robert De Lorenzo, MD, MSM, UT Health San Antonio; Study Director: Romeo Fairley, MD, MPH, UT Health San Antonio; Study Director: Alan Peterson, PhD, ABPP, UT Health San Antonio; Study Director: Stacey Young-McCaughan, RN, PhD, UT Health San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Ketamine; Emergency Department; Emergency Room; Suicidal Ideation; Crisis Response Plan; Acute Suicidality; Intramuscular Ketamine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: HSC20220426H; UL1TR002645 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected de-identified participant data that underlie results in a publication will be shared in a peer-reviewed scientific publication once data analysis is complete.
• IPD Sharing Time Frame: Data will be made available upon conclusion of the study and dissemination of findings. It will be made available for five (5) years after the conclusion of the study.
• IPD Sharing Access Criteria: Links to study documents and data will be shared on website following publication of study results to enable the creation and refinement of related projects' study design and procedures.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No