A Phase 2/3 interventional study of Ketamine Hydrochloride and Crisis Response Plan in Suicide, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 2/3, Interventional, and Other
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Among 36 studies testing ketamine in Suicidal Ideation — 8 open to participants now, 9 under way, 3 of them phase 3. Ketamine · Suicidal Ideation.
Among the 36 studies testing ketamine in Suicidal Ideation, this one is the 17th largest by planned enrollment, is one of 2 that started in 2023, is one of 2 in phase 2/3, and was the 29th registered.
569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.
Browse Suicidal Ideation studies →8 of the 36 studies testing ketamine in Suicidal Ideation are open now, in 2 countries. Recruiting first, the newest first:
The University of Texas Health Science Center at San Antonio · Sites in United States
Ages 18–70
Joshua Rosenblat · Sites in Canada
Ages 18–70
The Royal's Institute of Mental Health Research · Sites in Canada
Ages 18–65
Lindsay Maguire, MD · Sites in United States
Ages 18–65
Children's Hospital of Eastern Ontario · Sites in Canada
Ages 12–17
By country, each count listing its studies:
Ketamine: first FDA approval 1970 (KETALAR). What it is approved for, and how studies give it, is on its page →
Of the 134 Suicidal Ideation studies recruiting now, 51 (38%) set no upper age limit and 79 (59%) stop at 75 or younger; 54 take children under 18; 32 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 12 · Phase 3 7 · Phase 4 8
First in 2012; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 80 across 469 interventional studies indexed under Suicidal Ideation.
Median enrollment 22 across the 36 interventional studies. Of the 15 that completed or were terminated, 9 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 36 have an industry lead sponsor. The 10 most frequent:
The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
The University of Texas Health Science Center at San Antonio has 2 studies filed under Suicidal Ideation — fewer than ten, so there is no comparison to draw.
4 of the studies testing ketamine in Suicidal Ideation that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05696691Phase 3The University of Texas Health Science Center at San AntonioKetamine & Crisis Response Plan for Suicidal Ideation in the ED | 2026-12-31 |
| NCT06891300Phase 3The Royal's Institute of Mental Health ResearchUnderstanding and Treating Suicidal Ideation With Ketamine | 2027-03 |
| NCT07810023Endeavor HealthIntramuscular Ketamine for Suicidal Patients in the Evanston Hospital Emergency Department for Suicidal Distress | 2027-03 |
| NCT05450432Massachusetts General HospitalLong-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression | 2027-05-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 36 studies testing ketamine in Suicidal Ideation, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
This study is a phase II/III Clinical Pilot Trial. The study participants will be randomized to one of two groups: IM ketamine plus Crisis Response Planning (intervention group) or usual care (control group). Prior to treatment, we will obtain demographic and contact information for patients and for a friend/family member as a collateral reporter of symptom change and safety. As part of informed consent, participants will be warned about the potential for temporary effects of ketamine and provided an enrollment card to inform other care providers of their participation in a ketamine study. Participants will be weighed and complete a series of brief survey assessments. Clinical assessments such as history, physical examination, and routine laboratory testing will be collected as part of usual care. Ketamine and Crisis Response Planning will be administered, and study assessments will be repeated at 120 minutes posttreatment. To ensure the highest level of patient safety, we are proposing only to include patients who have already been cleared for a psychiatric hospitalization. This will also allow for close monitoring of symptom changes during the initial hours and days following treatment. Outcome measures will be collected at two hours, 3 days, and 1 month after the intervention. Research staff will collect assessments by telephone interview and/or visits. Consistent with established protocols, staff will be trained and supervised by STRONG STAR mental health professionals with expertise in evidence-based processes for assessing and responding to suicide risk. Trained and experienced therapists are available to meet with participants to develop a Crisis Response Plan at University Hospital.
569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.
This study's planned enrollment of 24 is below the median of 80 across 469 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 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
Compared within Suicidal Ideation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals randomized to the experimental arm will receive 100mg intramuscular ketamine injection before completing the Crisis Response Plan. The average timeframe for the experimental arm is anticipated to be approximately 60 minutes of active treatment. Following ketamine administration, the subject will be monitored for 45 minutes with pulse oximetry and recurrent vital signs. The study team will record when the CRP is completed in relation to the ketamine injection.
Drug: Ketamine Hydrochloride · Behavioral: Crisis Response Plan
Individuals randomized to the no intervention arm will receive routine care from emergency providers and psychiatry staff.
100mg IM ketamine to be administered in conjunction with CRP. The ketamine injection will be administered first. Participants will be observed and have vital signs monitored for the first 45 minutes after administering medication in the ED, observing for immediate reactions. Afterwards, participants will continue to be monitored for potential late-term side effects on the inpatient unit. Ketamine will be given only after initial standard of care (SOC) treatment and screening studies have been initiated.
Also known as: Ketamine
Crisis Response Plan is a brief, empirically-validated, Cognitive-Behavioral Therapy-based one-time therapy, and its administration typically takes 30-60 minutes. It begins with a narrative assessment (allowing patients to "tell their story") and concludes with collaboratively constructed plan that outlines strategies for the patient's self-management of future acute suicidal crises. Patients who engage in CRP are given an index card to keep with them that summarizes the emotional management strategies that they collaboratively generate with the CRP provider.
Also known as: CRP
Feasibility of study interventions
Number of enrolled subjects completing treatment within study parameters, with safety and side-effect profiles at or lower than published rates.
Time frame: 30 days
Change in Beck Scale for Suicidal Ideation (SSI) Score
The Beck Scale for Suicidal Ideation (SSI) is a 21-item measurement that evaluates the presence and intensity of suicidal thoughts. Each item is scored on a scale from 0-2 with a total score of 0-38; with higher scores indicating higher levels of suicidal ideation.
Time frame: Baseline to 30 days
Change in Depressive Symptoms Index-Suicidality Subscale (DSI-SS) Score
The Depressive Symptoms Index-Suicidality Subscale (DSI-SS) is a 4-item measure of suicidal ideation. Respondents rate each item on a 4-point scale ranging from 0-3. Responses are summed, and higher scores reflect more severe suicidal ideation (range: 0-12).
Time frame: Baseline to 30 days
Change in Suicide Visual Analog Scale (S-VAS) Score
The Suicide Visual Analog Scale is a 1-item momentary assessment to evaluate severity of suicidal ideation. The item is scored from 0-100 and the total possible score range for the scale is therefore also 0-100. Lower scores indicate less extreme current urges toward self harm, whereas higher scores are indicative of more severe urges.
Time frame: Baseline to 30 days
Plan to share: Yes — All collected de-identified participant data that underlie results in a publication will be shared in a peer-reviewed scientific publication once data analysis is complete.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be made available upon conclusion of the study and dissemination of findings. It will be made available for five (5) years after the conclusion of the study.
Access criteria: Links to study documents and data will be shared on website following publication of study results to enable the creation and refinement of related projects' study design and procedures.
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Dec 2026, 47 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Apr 2026 → Dec 2026 and completion Dec 2026 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
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 →