Recruiting

Phase 2

Ketamine & CRPAlleviating Suicidality by Combining Psychotherapy and IM Ketamine for Rapid Treatment in the Emergency Department

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07868913

Conditions

Suicidal Ideation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Ketamine Injectable Solution

Placebo Injection

Crisis Response Plan

Safety Planning

Study Details

Brief summary:

Participants are asked to take part in this research study after coming to the Emergency Department with thoughts or behaviors of seriously hurting themselves. There are very few resources to treat acute suicidal thoughts or behaviors in an emergency department. The purpose of this study is to evaluate the effectiveness of combining an intramuscular (IM) injection of ketamine and Crisis Response Planning (CRP), a single, 45-60 minute psychological intervention with a therapist, to quickly reduce suicidal thoughts in patients treated in an emergency department (ED) prior to being admitted to the hospital.

Conditions

Suicidal Ideation

Study ID

NCT07868913

Start date

Sep 30, 2026

Status verified date

Oct, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

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 anticipated to be admitted as an inpatient at UH or CRDAMC based on the ED and admitting providers determination that the patient warrants hospitalization for suicidality and the capacity of the institution to admit the patient.
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 determined to be the priority of treatment relative to treatment of the suicidal thoughts and behaviors.
Acute intoxication with clinically significant symptoms as determined by the ED provider to significantly increase the risk of participation (e.g., potential interaction with ketamine) or render the patient unable to consent.
The patient is not capable of understanding the research procedures and providing informed consent for themselves as determined by the research staff obtaining informed consent in consultation with the patient's ED provider.
Admittance to and treatment in an ED for acute suicidality within the past 30 days as determined by self-report, or if available, hospital records.
Lack of reliable means to be available for follow-up assessments (e. g, working mobile phone) as determined by self-report.
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 with ketamine as determined by the patient's ED provider.
Pregnancy as determined by pregnancy testing, or self-report of breast feeding.
Known hypersensitivity to ketamine as determined by self-report.
Legal or illegal use of ketamine in the previous 90 days as determined by self-report.
End-stage or severe cardiovascular (e.g., acute coronary syndrome (ACS) or decompensated heart failure), end-stage or severe liver, or kidney disease as determined by the ED chart history and ED provider's exam.
Patient is a prisoner as determined by prisoner escort.
Patient is physically restrained or actively under custody of law enforcement.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine plus CRP

Ketamine is administered and Crisis Reponse Planning developed for participants

experimental: Ketamine plus Safety plan control

Ketamine is administered and the Safety plan control administered as standard of care at discharge

experimental: Placebo plus CRP

Placebo is administered and Crisis Reponse Planning developed for participants

placebo comparator: Placebo plus Safety plan control

Placebo is administered and the Safety plan control administered as standard of care at discharge

Interventions

Ketamine Injectable Solution

1 mg.kg IM ketamine is administered after enrollment and randomization

Placebo Injection

Placebo is administered after enrollment and randomization

Crisis Response Plan

Crisis Response Planning is a collaborative, patient-centered psychosocial intervention that begins with a narrative assessment and concludes with the development of a personalized plan that outlines a series of self-regulatory strategies for managing acute emotional distress

Safety Planning

The Safety Planning intervention (provided as standard of care at discharge) includes a brief review of current suicide risk, provides patients with a suite of cognitive tools for avoiding future acute crises, and allows for a discussion and teach-back period to ensure patients' understanding of and willingness to use the plan

Primary outcome measure

Depressive Symptoms Index - Suicidality Subscale (DSI-SS) [ Time Frame: Baseline, 24 hours and 28 days ]

Central Contacts and Locations

Central contacts

Robert DeLorenzo, MD

210-567-4786 DeLorenzo@uthscsa.edu

Stephanie Perez, MHA

210 450 8973 perezs11@uthscsa.edu

Locations

University Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Robert DeLorenzo, MD

210 567-4292 delorenzo@uthscsa.edu

Stephanie Martinez, MHA

210 450-8566 martinezs13@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

Oct 9, 2026

Last verified

Oct, 2026

Keywords

Psychotherapy
Crisis Response Planning
Intramuscular ketamine
Emergency department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.