Recruiting
Phase 2
Phase 3

Ketamine & Crisis Response Plan

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT05696691

Conditions

Suicide

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Ketamine Hydrochloride

Crisis Response Plan

Study Details

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

Study ID

NCT05696691

Start date

Jan 6, 2023

Status verified date

Apr, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

no intervention: Treatment as Usual

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

Interventions

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.

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.

Primary outcome measure

  • Feasibility of study interventions [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Stehanie Perez, MHA

2104508973perezs11@uthscsa.edu

Locations

University Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Robert DeLorenzo, MD

210-567-4292delorenzo@uthscsa.edu

Principal Investigator:

Robert A De Lorenzo, MD

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Apr 11, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-04-11.