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

NCT07810023 | Enrolling By Invitation DMC

• 1 other identifier: IRB2026-0112
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal; Suicidal Ideation; Suicidal Ideation and Behavior; Depression / Major Depressive Disorder

Keywords

Suicidal Crisis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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 1-Hour Post-dose

• Change from pre-dose average Suicidal Ideation Attributes Scale (SIDAS) score at 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

  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

  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

  From the first enrollment to the end of the last enrollment (~6 months)

Other Outcomes (1)

• Average Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Severity Score

  Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and the entire 6-month study period.

Study Arms (1)

Dosing Cohort: ketamine

EXPERIMENTAL

Group that receives IM ketamine

Drug: Ketamine (0.5 mg/kg)

Interventions

Ketamine (0.5 mg/kg) DRUG

Single intramuscular dose of ketamine (0.5 mg/kg)

Dosing Cohort: ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).
• Admitted to the Evanston Hospital ED
• Assessed for Suicidal Ideation by the Crisis Team
• Over the age of 18
• Pregnant individuals
• Individuals who were participants in the Dosing Cohort

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health Evanston Hospital

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Behavior; Depression; Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: 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

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: September 9, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

US (1)