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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | All patients will receive the experimental drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Patients will receive 0.2mg/kg of IV ketamine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Safety of use of ketamine for SI in the ED, as assessed by number and severity of reported serious adverse outcomes. | 2 hours |
| Provider and Nursing Attitudes toward use of Ketamine for Suicidal Patients in the ED [Feasibility] | 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. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Suicidal Ideation | Change 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. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Maguire, MD | Contact | 913-588-3580 | lmaguire@kumc.edu | |
| Lucas Lemar | Contact | llemar@kumc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Strawberry Hill Campus | Not yet recruiting | Kansas City | Kansas | 66101 | United States |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D059020 | Suicidal Ideation |
| D003863 | Depression |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Hospital Length of Stay | Impact of administration of ketamine on overall psychiatric hospital length of stay. | up to 2 weeks |
| University of Kansas Medical Center Emergency Department | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |