A Phase 2 interventional study of Ketamine Injectable Solution and Placebo Injection in Suicidal Ideation, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 2, Interventional, and Treatment
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.
Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation requiring and anticipated to be for admitted as an inpatient to 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 will be identified by an ED staff member.
Following consent, participants will complete the baseline assessment at the hospital in the patient's assigned room. Once confirmed eligible, the participant will be randomly assigned into one of the four study arms.
The study injection (either the ketamine (1 mg/kg) or saline placebo (volume matched to the equivalent dose of ketamine) for injection) will be administered in the ED by Nursing staff and the CRP will be administered by a trained member of the research team. Participants randomized to the safety plan control condition will receive their plan from hospital staff at discharge from the hospital as standard of care.
Following the study injection, the ED clinical staff are responsible for monitoring participants for one hour for common side effects of ketamine including symptoms of dizziness, nausea, vomiting, confusion, or dissociative episodes. Patients' vital signs and pulse oximetry will also be monitored in accordance with the facility ED protocol for sub-dissociative administration of ketamine (e.g. frequent vital signs for 45 minutes).
Follow-up assessments will be completed at 24-hours, 48-hours, 72-hours, 7-days, 28-days, and 56-days after study treatment in the STRONG STAR offices, or by phone.
530 studies on the registry are indexed under Suicidal Ideation; 198 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 440 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 443 studies on the registry; 88 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 35 (55%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Ketamine is administered and Crisis Response Planning developed for participants
Drug: Ketamine Injectable Solution · Behavioral: Crisis Response Plan
Ketamine is administered and the Safety plan control administered as standard of care at discharge
Drug: Ketamine Injectable Solution · Other: Safety Planning
Placebo is administered and Crisis Response Planning developed for participants
Other: Placebo Injection · Behavioral: Crisis Response Plan
Placebo is administered and the Safety plan control administered as standard of care at discharge
Other: Placebo Injection · Other: Safety Planning
1 mg.kg IM ketamine is administered after enrollment and randomization
Also known as: Ketamine Intramuscular (IM) Injection
Placebo is administered after enrollment and randomization
Also known as: Sodium Chloride Solution 0.9%
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
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
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.
Time frame: Baseline, 24 hours and 28 days
Suicide Visual Analogue Scale (S-VAS)
A scale scored from 0=none to 100=extreme urge to commit suicide
Time frame: Baseline to 56 days
Beck Scale for Suicidal Ideation (SSI)
A scale with 19 possible items scored from 0-2 to give a possible score between 0-38 with a higher score indicating greater suicidal ideation. If the participant scores 0 (no indication of suicidal ideation) on questions 4 and 5, the survey is stopped at that point, otherwise the survey is continued.
Time frame: Baseline to 72 hours
Plan to share: Yes — We will follow institutional policies regarding presentations and publications and the International Committee of Medical Journal Editors (ICMJE) "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals"
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ketamine
The University of Texas Health Science Center at San Antonio →