Health TrialsbyHealthPanel

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

ConditionsSuicideSuicidal IdeationDepression
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLindsay Maguire, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acutely Suicidality ("yes" answer to any of items 4 or 5 on C-SSRS "Suicidal Ideation" category)

Require inpatient stabilization for SI or actions based on clinical observation and interview

Are accepted for psychiatric stabilization at the University of Kansas Medical Center's Strawberry Hill campus

Have a Glasgow Coma Score (GCS) of 15

Disqualifiers

Current or past history of psychosis

Current or recent (past 4 weeks) symptoms of mania/hypomania as defined by Young Mania Rating Scale (YRMS) score of 12 or greater

History of ketamine use disorder

History of liver transplant

Trial design

Design model

Single group

Treatments tested in this trial

  • Ketamine

    Drug

    Patients will receive 0.2mg/kg of IV ketamine

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: KetamineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 hours
2

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.

Time frame
2 hours

Secondary outcomes

1

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.

Time frame
72 hours
2

Hospital Length of Stay

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

Time frame
up to 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lindsay Maguire, MD

Lead sponsor

University of Kansas Medical Center

Sponsor institution

Source ClinicalTrials.gov
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