An interventional study of Ketamine (0.5 mg/kg) in Suicidal, Suicidal Ideation and Suicidal Ideation and Behavior, sponsored by Endeavor Health. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Endeavor Health · Not applicable, Interventional, and Other
This pilot study aims to evaluate the feasibility and acceptability of administering intramuscular ketamine for the acute reduction of suicidal distress during psychiatric boarding at the Evanston Hospital ED. This study also aims to identify and describe the broader patient population who present to the Evanston Hospital ED in suicidal distress. This study includes several cohorts. A small (n=8) dosing cohort will receive an IM injection of ketamine. Additionally, an ED staff cohort and a research staff cohort can complete optional surveys to provide feedback about study procedures. Lastly, a chart review will be conducted after the completion of the study to determine the volume and patterns of patients who present to Evanston Hospital ED in suicidal distress.
This pilot study aims to evaluate the feasibility and acceptability of administering intramuscular ketamine for the acute reduction of suicidal distress during psychiatric boarding at the Evanston Hospital ED, with a focus on ketamine's effect on suicidal distress specifically rather than broader antidepressant outcomes. To accomplish this, a dosing cohort of 8 participants who meet all eligibility criteria, retain decision-making capacity, and have voluntarily consented to inpatient psychiatric hospitalization will receive a single 0.5 mg/kg intramuscular ketamine injection. Participants will complete clinical assessments before and after administration, undergo a mandatory one-hour observation period, and complete a brief exit survey. A retrospective chart review will identify a comparator group of ED patients presenting in suicidal crisis during the same enrollment period, applying broader inclusion criteria to characterize the general population of such patients at Evanston Hospital. ED clinical staff and research team members will each be invited to complete optional surveys assessing their perceptions of the protocol's feasibility and acceptability, with ED staff surveys administered anonymously. It is anticipated that the protocol will not unduly contribute to psychiatric boarding time or overall ED length of stay, and findings will provide preliminary evidence that may inform the design of future efficacy trials or support the development of a standardized clinical protocol. In this pilot study, 0.5 mg/kg of intramuscular ketamine hydrochloride will be administered to a dosing cohort of 8 participants experiencing acute suicidal distress associated with unipolar depression during their psychiatric boarding period at the Evanston Hospital Emergency Department. Eligible participants must meet all study eligibility criteria, retain decision-making capacity, and have already provided voluntary consent to inpatient psychiatric hospitalization prior to enrollment. Participants in the dosing cohort will complete questionnaires and clinical assessments evaluating suicidality and mental status at baseline and following ketamine administration. After administration, participants will undergo a mandatory one-hour observation period to monitor safety and assess post-dose efficacy. Upon completion of the observation period, participants will complete a brief exit survey assessing their satisfaction with and perceived helpfulness of the study procedures. Electronic medical record data will be collected for the dosing cohort from ED admission through ED discharge, and the time elapsed between each clinical encounter will be tracked as participants progress through standard ED clinical procedures and study activities.
569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.
This study's planned enrollment of 8 is below the median of 80 across 469 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →Endeavor Health is the lead sponsor of 111 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for the dosing cohort:
Exclusion Criteria for dosing cohort:
Inclusion Criteria for Chart Review Cohort:
Exclusion Criteria for Chart Review Cohort:
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group that receives IM ketamine
Drug: Ketamine (0.5 mg/kg)
Drug page: Ketamine
Single intramuscular dose of ketamine (0.5 mg/kg)
Difference in time spent in the ED for dosing participants vs non-dosing patients
We will assess the time burden of study procedures on ED standard procedures by comparing the average time for dosing participants with that for non-dosing participants. Time will be measured in minutes.
Time frame: Up to 7 Days
Average dosing participants' scores of investigator-developed feasibility and acceptability survey.
Dosing participants l will respond to surveys rating how acceptable and feasible they found the procedure during their stay in the ED. We will sum the quantitative items and calculate the average for each group.
Time frame: Up to 7 days
Average ER personnel score of investigator-developed feasibility and acceptability survey
ER personnel will respond to surveys rating how acceptable and feasible they found the procedure. We will sum the quantitative items and calculate the average for each group.
Time frame: Up to 7 days
Change in average pre-dose vs. post-dose Brief Dissociative Symptoms Scale (DSS-B) scores
Pre-dose to post-dose difference in average Brief Dissociative Symptoms Scale (DSS-B) scores for dosing participants
Time frame: Pre-dose to 1-Hour Post-dose
Change from pre-dose average Suicidal Ideation Attributes Scale (SIDAS) score at 1-hour post-dose
Change from the pre-dose average Suicidal Ideation Attributes Scale (SIDAS) score at 1-hour post-dose for dosing participants
Time frame: Pre-dose to 1-Hour Post-dose
Change in average Suicide Crisis Inventory-2 Short Form (SCI-2-SF) from pre-dose to 1-hour post-dose
Change in average Suicide Crisis Inventory-2 Short Form (SCI-2-SF) from pre-dose to 1-hour post-dose for dosing
Time frame: Pre-dose to 1-hour post-dose
Total patients presenting to ED and assessed by Crisis Team from the start of enrollment to the end of enrollment
Total patients presenting to ED and assessed by ED Crisis Team from the start of enrollment to the end of enrollment (estimated to be 6 months)
Time frame: From the first enrollment to the end of the last enrollment (~6 months)
Average age of ED patients assessed by the ED crisis team during enrollment
Average age of ED patients assessed by the ED crisis team via chart reviews from the time that the first dosing participant is enrolled to the time the last dosing participant completes enrollment (estimated to be 6 months)
Time frame: From the first enrollment to the end of the last enrollment (~6 months)
Change in average pre-dose Clinician's Global Assessment of Suicidal Ideation (CGA) score to core at 1-hour post-dose
Change in average pre-dose Clinician's Global Assessment of Suicidal Ideation (CGA) score to 1 Hour post-dose score for dosing participants
Time frame: Pre-dose to 1-hour post-dose
Participant recruitment rate
Recruitment rate defined as the number of participants approached about the study per month.
Time frame: Start of recruitment to enrollment of the final dosing participant (Month 6)
Participant Enrollment Rate
Average monthly enrollment rate, calculated as the total number of participants who provided written informed consent per month
Time frame: Start of enrollment to end of enrollment phase (Month 6)
Rate of Recruitment to Enrollment
The success rate of enrollment, calculated as the total number of participants enrolled divided by the total number of individuals approached/screened
Time frame: Recruitment start to end of enrollment at Month 6
Number of Participants Presenting to the Emergency Department by Day of the Week
The total count of study participants presenting to the emergency department, categorized by the specific day of the week admitted to the ED(Monday through Sunday).
Time frame: Enrollment start to end of 6 month enrollment period
Time of Day Patients Presented to the Emergency Department.
The total count of study participants presenting to the emergency department, categorized by time of day the patient was admitted to ED based on shift times. Shift during which the patient presented: Day Shift (07:00-14:59), Evening Shift (15:00-22:59), or Night Shift (23:00-06:59)
Time frame: Enrollment start to end of 6 month enrollment period
Average Suicide Crisis Syndrome Checklist (SCS-C) score
The Suicide Crisis Syndrome Checklist (SCS-C) score tracked during acute emergency department (ED) crisis team evaluations (score range: 0-15, where higher scores indicate greater severity of acute suicide crisis). Data are extracted via retrospective clinical chart review of all ED crisis presentations.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and the entire 6-month study period.
Average Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Severity Score
The average scores derived from the total amount of C-SSRS assessments administered by ED crisis evaluations via retrospective medical chart reviews conducted following the 6-month enrollment period. The C-SSRS Suicidal Ideation subscale evaluates the severity of thoughts on an ordinal scale from 0 (No Suicidal Ideation) to 5 (Active Suicidal Ideation with Specific Plan and Intent). Higher scores indicate a greater severity of suicidal ideation.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and the entire 6-month study period.
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Studies of the drug tested here: Ketamine