Trial | NCT04266288  Report issue

Title

Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department
Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    29
The purpose of this study is to examine the effect of a low-dose ketamine infusion on depression symptoms within the Emergency Department (ED) visit, and healthcare utilization after leaving the ED, when administered in the ED for depression or suicidal ideation.
Patients will be identified based on either a chief complaint of suicidal ideation, suicide attempt, or severe depression, or if the patient indicates during intake assessment that they have thoughts of harming or killing their self. Identified patients will be assessed by the ED provider for inclusion and exclusion criteria. If the patient is a candidate for the trial and gives their informed consent for enrollment, they will be randomized to receive either ketamine or placebo by a computer program that maintains blinding. The patient will be assessed by psychiatry for disposition and treatment plan prior to receiving the study drug, and will be reassessed four hours after the infusion. Thirty days after the patient leaves the hospital (either leaves from the ED or is discharged from inpatient admission), they will be contacted to follow up on their healthcare utilization after discharge.
Study Started
Oct 18
2019
Primary Completion
May 31
2020
Study Completion
May 31
2020
Last Update
Sep 01
2020

Drug Ketamine

Active drug

  • Other names: Ketalar

Drug Sodium Chloride 0.9%

Placebo

  • Other names: Normal Saline

Ketamine Experimental

Ketamine 0.5 mg/kg in 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose.

Placebo Placebo Comparator

0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose

Criteria 

Inclusion Criteria:

Adults 18 years of age and older
Presenting to the ED with a chief complaint of severe depression or suicidality, or presenting to the ED with any other chief complaint but answering "yes" to "Thoughts of harming/killing yourself?" during intake/triage

Exclusion Criteria:

Acute mania or psychosis
Enrollment in trial during a prior emergency department visit
History of ketamine abuse or dependence
Known hypersensitivity to ketamine
Acute intoxication with any drug of abuse (including alcohol)
Pregnancy or lactation
Any condition that would place the patient at serious risk of harm from an increase in blood pressure (e.g. history of intracerebral hemorrhage, aneurysmal vascular disease, or arteriovenous malformation)
Assessing provider does not want to enroll patient for any other reason, based on their clinical judgement
No Results Posted