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

NCT07868913 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00002358HT9425-24-1-0519
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Keywords

Psychotherapy; Crisis Response Planning; Intramuscular ketamine; Emergency department

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms Index - Suicidality Subscale (DSI-SS)

  A 4 item scale scored from 0-3 for each item and summed to give a total between 0-12 with a higher score indication greater suicidal ideation.

  Baseline, 24 hours and 28 days

Secondary Outcomes (2)

• Suicide Visual Analogue Scale (S-VAS)

  Baseline to 56 days

• Beck Scale for Suicidal Ideation (SSI)

  Baseline to 72 hours

Study Arms (4)

Ketamine plus CRP

EXPERIMENTAL

Ketamine is administered and Crisis Reponse Planning developed for participants

Drug: Ketamine Injectable Solution; Behavioral: Crisis Response Plan

Ketamine plus Safety plan control

EXPERIMENTAL

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

Drug: Ketamine Injectable Solution; Other: Safety Planning

Placebo plus CRP

EXPERIMENTAL

Placebo is administered and Crisis Reponse Planning developed for participants

Other: Placebo Injection; Behavioral: Crisis Response Plan

Placebo plus Safety plan control

PLACEBO COMPARATOR

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

Other: Placebo Injection; Other: Safety Planning

Interventions

Ketamine Injectable Solution DRUG

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

Also known as: Ketamine Intramuscular (IM) Injection

Ketamine plus CRP; Ketamine plus Safety plan control

Placebo Injection OTHER

Placebo is administered after enrollment and randomization

Also known as: Sodium Chloride Solution 0.9%

Placebo plus CRP; Placebo plus Safety plan control

Crisis Response Plan BEHAVIORAL

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

Also known as: CRP

Ketamine plus CRP; Placebo plus CRP

Safety Planning OTHER

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

Also known as: Safety Plan Control

Ketamine plus Safety plan control; Placebo plus Safety plan control

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 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.

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 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• United States Department of Defense: collaborator

Study Sites (2)

Carl R Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

NOT YET RECRUITING

University Hospital

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Emergencies

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Robert DeLorenzo, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert DeLorenzo, MD

CONTACT

210-567-4786; DeLorenzo@uthscsa.edu

Stephanie Perez, MHA

CONTACT

210 450 8973; perezs11@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators, study staff, hospital staff administering the medication, and participants will be blind to the administration of ketamine or the normal saline control. Pharmacy staff will prepare the drug per the physician order set and so will not be blinded to the treatment condition. However, because participants, interventionalists, and study staff cannot be blind to the behavioral therapies being delivered, only the independent evaluators will be blind to the behavioral treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study design is a four-arm 2x2 factorial design randomized clinical trial (RCT)

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: A year after study completion summary results will be shared in ClinicalTrials.gov, and after data analysis and journal acceptance, in a peer-review journal.

Locations

US (2)