Intramuscular Ketamine for Suicidal Patients in the Evanston Hospital Emergency Department for Suicidal Distress

N/AEnrolling By InvitationNCT07810023

Endeavor Health8 enrolled

Overview

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria for Chart Review Cohort: 1. Pregnant individuals 2. Individuals who were participants in the Dosing Cohort

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Intramuscular Ketamine for Suicidal Patients in the Evanston Hospital Emergency Department for Suicidal Distress

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes