Suicidal, Suicidal Ideation, Suicidal Ideation and Behavior, Depression / Major Depressive Disorder
Conditions
Keywords
Suicidal Crisis
Brief 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. 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.
Interventions
Single intramuscular dose of ketamine (0.5 mg/kg)
Sponsors
Endeavor Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for the dosing cohort: 1. Admitted to the Evanston Hospital ED and met criteria for SCS 2. Awaiting voluntary admission to the Evanston Hospital inpatient psychiatric unit 3. Above the age of 18. 4. Ability to provide written informed consent.
Exclusion criteria
for dosing cohort: 1. Patients under the age of 18 2. Pregnant individuals (Individuals of child-bearing potential will be given a pregnancy test) 3. Active psychosis or carry a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder mixed, or bipolar disorder with a history of psychotic episodes 4. 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. 5. Current substance use disorder or significant history of substance abuse 6. Unstable vital signs, including moderate or severe hypertension that is not controlled with medication 7. History of an adverse reaction to ketamine or esketamine 8. 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). 9. 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). 10. 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). Inclusion Criteria for Chart Review Cohort: 1. Admitted to the Evanston Hospital ED 2. Assessed for Suicidal Ideation by the Crisis Team 3. Over the age of 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average ER personnel score of investigator-developed feasibility and acceptability survey | 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. |
| Difference in time spent in the ED for dosing participants vs non-dosing patients | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in average Suicide Crisis Inventory-2 Short Form (SCI-2-SF) from pre-dose to 1-hour post-dose | 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 |
| Total patients presenting to ED and assessed by Crisis Team from the start of enrollment to the end of enrollment | From the first enrollment to the end of the last enrollment (~6 months) | 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) |
| Average age of ED patients assessed by the ED crisis team during enrollment | From the first enrollment to the end of the last enrollment (~6 months) | 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) |
| Change in average pre-dose Clinician's Global Assessment of Suicidal Ideation (CGA) score to core at 1-hour post-dose | Pre-dose to 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 |
| Participant recruitment rate | Start of recruitment to enrollment of the final dosing participant (Month 6) | Recruitment rate defined as the number of participants approached about the study per month. |
| Participant Enrollment Rate | Start of enrollment to end of enrollment phase (Month 6) | Average monthly enrollment rate, calculated as the total number of participants who provided written informed consent per month |
| Rate of Recruitment to Enrollment | Recruitment start to end of enrollment at Month 6 | The success rate of enrollment, calculated as the total number of participants enrolled divided by the total number of individuals approached/screened |
| Time of Day Patients Presented to the Emergency Department. | Enrollment start to end of 6 month enrollment period | 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) |
| Number of Participants Presenting to the Emergency Department by Day of the Week | Enrollment start to end of 6 month enrollment period | 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). |
| Average Suicide Crisis Syndrome Checklist (SCS-C) score | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and the entire 6-month study period. | 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. |
| Change in average pre-dose vs. post-dose Brief Dissociative Symptoms Scale (DSS-B) scores | Pre-dose to 1-Hour Post-dose | Pre-dose to post-dose difference in average Brief Dissociative Symptoms Scale (DSS-B) scores for dosing participants |
| Change from pre-dose average Suicidal Ideation Attributes Scale (SIDAS) score at 1-hour post-dose | Pre-dose to 1-Hour Post-dose | Change from the pre-dose average Suicidal Ideation Attributes Scale (SIDAS) score at 1-hour post-dose for dosing participants |
Countries
United States
Outcome results
None listed