NCT05696691 Ketamine & Crisis Response Plan for Suicidal Ideation in the ED
| NCT ID | NCT05696691 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Suicide |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-01-06 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2023-01-06 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Robert De Lorenzo, MD, MSM
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT05696691 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Suicide. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05696691 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05696691 currently recruiting?
Yes, NCT05696691 is actively recruiting participants. Contact the research team at perezs11@uthscsa.edu for enrollment information.
Where is the NCT05696691 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT05696691 clinical trial?
NCT05696691 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Robert De Lorenzo, MD, MSM at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 24 participants.