Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department

MercyOne Des Moines Medical Center

Status and phase: Completed; Phase 4

Conditions: Suicidal Ideation; Depression Acute; Depression and Suicide; Depression; Depression Severe

Treatments: Drug: Sodium Chloride 0.9%; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04266288

MMC2019-46

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

Ketamine

Experimental group

Description:

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

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Sodium Chloride 0.9%