ketamine
DrugPatients will receive 0.2mg/kg of IV ketamine
NCT Number: NCT06085937
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
University of Kansas Medical Center Emergency Department, Kansas City, Kansas, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive 0.2mg/kg of IV ketamine
Time frame: 2 hours
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
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: 72 hours
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: up to 2 weeks
Impact of administration of ketamine on overall psychiatric hospital length of stay.
Contact information is provided by the study sponsor or research team.
Lindsay Maguire, MD
Other
Feasibility and Safety of Single Dose Ketamine for Acutely Suicidal Patients in the Emergency Department
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04572321
Anxiety Disorders, Behavior
Dallas, Texas, United States
View Trial DetailsNCT05021224
Behavior, Behavioral Symptoms
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT04893447
Adolescent, Adult
Boise, Idaho, United States
View Trial DetailsNCT04495543
Behavior, Behavioral Symptoms
Toronto, Ontario, Canada
View Trial Details