Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06085937
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site: 25
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

There is currently no readily available pharmacologic intervention for suicidal ideation, a true psychiatric emergency, in the Emergency Department (ED). Investigators aim to trial low-dose, intravenous ketamine, a drug with well-established use in treatment-resistant depression, for patients who present to the ED with suicidal ideation.

Condition or Disease	Intervention/Treatment	Phase
Suicide; Suicidal Ideation; Depression	Drug: Ketamine	Phase 1

Detailed Description

In this phase one trial, the investigators' objective is to establish the safety and feasibility of the study dose and route of administration, as well as to provide preliminary data on efficacy in reduction of depressive and suicidal symptoms as well as length of stay. Select patients will be given 0.2mg/kg of ketamine IV and observed in the ED for two hours. Vital signs and symptoms will be monitored. Patients will then be transferred to an admitting psychiatric hospital for definitive care as per standard of care. Surveys will be administered at times 0, 2 hours, 24 hours, and 72 hours to assess depressive and suicidal symptoms. ED providers and nursing staff will be asked to complete a short survey assessing ease of use and feasibility for ED administration for this purpose.

Specific aims are as follows:

1. To determine the safety of ketamine as a single IV dose in the ED for acutely suicidal patients.

2. To determine the feasibility of ketamine administration in the ED for the acutely suicidal patient.

3. To determine the impact of ketamine administration on depression and suicidal ideation in the acute phase as measured by the MADRS and C-SSRS.

4. To determine the impact on hospital length of stay calculated from ED arrival until discharge from admitting psychiatric hospital.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility and Safety of Single Dose Ketamine for Acutely Suicidal Patients in the Emergency Department
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine All patients will receive the experimental drug.	Drug: Ketamine; Patients will receive 0.2mg/kg of IV ketamine

Outcome Measures

Primary Outcome Measures

1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [2 hours]

   Safety of use of ketamine for SI in the ED, as assessed by number and severity of reported serious adverse outcomes.

2. Provider and Nursing Attitudes toward use of Ketamine for Suicidal Patients in the ED [Feasibility] [2 hours]

   A questionnaire will be given to providers and nursing staff to assess [1] perceived safety, [2] provider comfort, [3] perceived efficacy, and [4] perceived feasibility for ED use as rated on a Likert scale from 1-5, with 5 relaying best perceived outcomes.

Secondary Outcome Measures

1. Change in Suicidal Ideation [72 hours]

   Reduction of SI in ED patients after ketamine administration, as measured by the Columbia Suicide Severity Rating Scale (ideation subscore range 1-5, with higher number indicating increasing suicidal ideation; intensity subscore rating 2-25, with higher number indicating greater severity of suicidal ideation) and Montgomery-Asberg Depression Rating Scale.

2. Hospital Length of Stay [up to 2 weeks]

   Impact of administration of ketamine on overall psychiatric hospital length of stay.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acutely Suicidal (passive or active)

• GCS 15

Exclusion Criteria:

• History of psychosis

• Clinical intoxication

• Hypertension (SBP > 180 or DBP > 100)

• Hypotension (SBP < 90)

• Pregnancy

• Imprisonment or inability to consent

• Allergy, intolerance, or previous adverse reaction to ketamine

• The treating physician determines that the patient is not a good candidate for the study

• Acute medical condition requiring admission to a medical service

• Involuntary status

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Strawberry Hill Campus	Kansas City	Kansas	United States	66101
2	University of Kansas Medical Center Emergency Department	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT06085937
• Other Study ID Numbers: STUDY00150830
• First Posted: Oct 17, 2023
• Last Update Posted: Oct 17, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Emergencies; Suicide; Suicidal Ideation; Ketamine

Study Results

No Results Posted as of Oct 17, 2023