Skip to content
RecruitingPhase 2

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

NCT07868913 · ASPIRED · The University of Texas Health Science Center at San Antonio

Recruiting
Status
Accepting participants
Phase 2
Phase
200
Target enrolment
2
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over Baseline, 24 hours and 28 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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 University Health (UH) or Carl R Darnall Army Medical Center (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.

Where

2 study sites

FacilityCityRegionCountry
Carl R Darnall Army Medical Center (CRDAMC)Fort HoodTexasUnited States
University Hospital (UH)San AntonioTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07868913 on ClinicalTrials.gov →

Last updated in the registry 2026-10-15. Registry records change; this page reflects the data build of 2026-10-30.

Related

Where this trial sits