SuicidalKEDS-CNCT07810023
Intramuscular Ketamine for Suicidal Patients in the Evanston Hospital Emergency Department for Suicidal Distress
A study testing Ketamine (0.5 mg/kg) in people with Suicidal and Suicidal Ideation, run by Endeavor Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal, Suicidal Ideation, Suicidal Ideation and Behavior
- What is being tested?
- Ketamine (0.5 mg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the Evanston Hospital ED and met criteria for SCS
- Awaiting voluntary admission to the Evanston Hospital inpatient psychiatric unit
- Above the age of 18.
- Ability to provide written informed consent.
- Admitted to the Evanston Hospital ED
- Assessed for Suicidal Ideation by the Crisis Team
- Over the age of 18
Who cannot join
- Patients under the age of 18
- Pregnant individuals (Individuals of child-bearing potential will be given a pregnancy test)
- Active psychosis or carry a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder mixed, or bipolar disorder with a history of psychotic episodes
- Individuals whose current ED visit was due to a suicide attempt defined by "actual attempt" on the C-SSRS and which resulted in a score greater than zero on the Lethality/Potential Lethality/Medical Damage C-SSRS questions.
- Current substance use disorder or significant history of substance abuse
- Unstable vital signs, including moderate or severe hypertension that is not controlled with medication
Show all 12Show fewer
- History of an adverse reaction to ketamine or esketamine
- Any condition that, in the clinical opinion of the investigator, impairs capacity to provide informed consent (including but not limited to: seizure disorders, psychiatric conditions, neurological conditions, intellectual disabilities, neurodegenerative disorders, renal impairment, hepatic impairment, bleeding disorders, cardiovascular disease, pulmonary disease, or recent history of stroke, aneurysm, or malignancy).
- Any condition that, in the clinical opinion of the investigator contraindicates intramuscular injections (including but not limited to: current medications, current or recent infection, neuromuscular conditions, skin conditions, bleeding disorders, cardiovascular disease, ror recent myocardial infarction).
- Any condition that, in the clinical opinion of the investigator that contraindicates ketamine (including but not limited to: seizure disorders, psychiatric conditions, neurological conditions, intellectual disabilities, neurodegenerative disorders, renal impairment, hepatic impairment, bleeding disorders, cardiovascular disease, pulmonary disease, or recent history of stroke, aneurysm, or malignancy).
- Pregnant individuals
- Individuals who were participants in the Dosing Cohort
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Endeavor Health Evanston Hospital
Evanston, Illinois, 60201
About this study
Official title: Intramuscular Ketamine for Suicidal Patients in the Evanston Hospital Emergency Department for Suicidal Distress: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Suicidal, Suicidal Ideation, Suicidal Ideation and Behavior, Depression / Major Depressive Disorder
- Being tested
- Ketamine (0.5 mg/kg)
- Keywords
- Suicidal Crisis
- Medical subject headings
- Suicidal Ideation, Behavior, Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (0.5 mg/kg)Drug
Single intramuscular dose of ketamine (0.5 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Dosing Cohort: ketamine | Experimental | Group that receives IM ketamine Receives: Drug: Ketamine (0.5 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Pre-dose to 1-hour post-dose
Participant recruitment rate
Recruitment rate defined as the number of participants approached about the study per month.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and the entire 6-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicidalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed-method hybrid design: Dosing Cohort (pilot interventional): Tests the intervention, recruitment capacity, safety, and initial tolerability on a micro-scale (8 participants) - there is only one dosing arm Chart Review Cohort: Uses real-world clinical data to establish baseline demographics and ensure the small trial group reflects the actual clinical population. Survey Cohort (process evaluation): Gathers operational feedback from hospital and research staff to refine future protocol procedures
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederick Miller, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810023
- Sponsor's protocol ID
- IRB2026-0112
- Acronym
- KEDS-C
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Ketamine for Suicidal Patients in the Evanston Hospital Emergency Department for Suicidal Distress: A Pilot Study
- ClinicalTrials.gov ID
- NCT07810023
- Acronym / sponsor ID
- KEDS-C / IRB2026-0112
- Conditions
- Suicidal, Suicidal Ideation, Suicidal Ideation and Behavior, Depression / Major Depressive Disorder
- Keywords
- Suicidal Crisis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed-method hybrid design: Dosing Cohort (pilot interventional): Tests the intervention, recruitment capacity, safety, and initial tolerability on a micro-scale (8 participants) - there is only one dosing arm Chart Review Cohort: Uses real-world clinical data to establish baseline demographics and ensure the small trial group reflects the actual clinical population. Survey Cohort (process evaluation): Gathers operational feedback from hospital and research staff to refine future protocol procedures
| Arm | Type | Receives |
|---|---|---|
| Dosing Cohort: ketamine | Experimental | Drug: Ketamine (0.5 mg/kg)Group that receives IM ketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Admitted to the Evanston Hospital ED and met criteria for SCS
- Awaiting voluntary admission to the Evanston Hospital inpatient psychiatric unit
- Above the age of 18.
- Ability to provide written informed consent.
- Admitted to the Evanston Hospital ED
Key exclusion criteria (12 listed)
- Patients under the age of 18
- Pregnant individuals (Individuals of child-bearing potential will be given a pregnancy test)
- Active psychosis or carry a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder mixed, or bipolar disorder with a history of psychotic episodes
- Individuals whose current ED visit was due to a suicide attempt defined by "actual attempt" on the C-SSRS and which resulted in a score greater than zero on the Lethality/Potential Lethality/Medical Damage C-SSRS questions.
- Current substance use disorder or significant history of substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine (0.5 mg/kg)Single intramuscular dose of ketamine (0.5 mg/kg) | Drug | Dosing Cohort: ketamine |
Primary outcome
Difference in time spent in the ED for dosing participants vs non-dosing patients
Time frame: Up to 7 Days
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.
Average dosing participants' scores of investigator-developed feasibility and acceptability survey.
Time frame: Up to 7 days
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.
Average ER personnel score of investigator-developed feasibility and acceptability survey
Time frame: Up to 7 days
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.
12 secondary outcomes
Change in average pre-dose vs. post-dose Brief Dissociative Symptoms Scale (DSS-B) scores
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
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
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
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
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
Time frame: Pre-dose to 1-hour post-dose
Participant recruitment rate
Time frame: Start of recruitment to enrollment of the final dosing participant (Month 6)
Participant Enrollment Rate
Time frame: Start of enrollment to end of enrollment phase (Month 6)
Rate of Recruitment to Enrollment
Time frame: Recruitment start to end of enrollment at Month 6
Number of Participants Presenting to the Emergency Department by Day of the Week
Time frame: Enrollment start to end of 6 month enrollment period
Time of Day Patients Presented to the Emergency Department.
Time frame: Enrollment start to end of 6 month enrollment period
Average Suicide Crisis Syndrome Checklist (SCS-C) score
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and the entire 6-month study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine (0.5 mg/kg) in people with Suicidal and Suicidal Ideation, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in time spent in the ED for dosing participants vs non-dosing patients (time frame: Up to 7 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.