Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

NCT05696691 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: HSC20220426HUL1TR002645
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ketamine; Crisis Response Plan; Suicidal Ideation; Emergency Department; Acute Suicidality; Intramuscular Ketamine; Emergency Room

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Beck Scale for Suicidal Ideation (SSI) Score

  Baseline to 30 days

• Change in Depressive Symptoms Index-Suicidality Subscale (DSI-SS) Score

  Baseline to 30 days

• Change in Suicide Visual Analog Scale (S-VAS) Score

  Baseline to 30 days

Study Arms (2)

Ketamine and Crisis Response Plan (CRP)

EXPERIMENTAL

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; Behavioral: Crisis Response Plan

Treatment as Usual

NO INTERVENTION

Individuals randomized to the no intervention arm will receive routine care from emergency providers and psychiatry staff.

Interventions

Ketamine Hydrochloride DRUG

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.

Also known as: Ketamine

Ketamine and Crisis Response Plan (CRP)

Crisis Response Plan BEHAVIORAL

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.

Also known as: CRP

Ketamine and Crisis Response Plan (CRP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Suicidal Ideation; Emergencies

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Robert De Lorenzo, MD, MSM

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Stehanie Perez, MHA

CONTACT

2104508973; perezs11@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 25, 2023
• Study Start: January 6, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)