NCT06085937

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Lindsay Maguire, MD · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Suicide
• Suicidal Ideation
• Depression

Interventions

Type	Name	Description
DRUG	Ketamine	Patients will receive 0.2mg/kg of IV ketamine

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2023-10-17
• Last updated: 2026-04-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study