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

NCT ID: NCT04266288

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2020-05-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketamine

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Active drug

Placebo

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

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 0.9%

Intervention Type: DRUG

Placebo

Interventions

Ketamine

Active drug

Intervention Type: DRUG

Sodium Chloride 0.9%

Placebo

Intervention Type: DRUG

Other Intervention Names

Ketalar; Normal Saline

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MercyOne Des Moines Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Bress, PharmD

Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Bress, PharmD

Role: PRINCIPAL_INVESTIGATOR

MercyOne Des Moines Medical Center

Adnan Iqbal, MD

Role: PRINCIPAL_INVESTIGATOR

MercyOne Des Moines Medical Center

Locations

MercyOne Des Moines Medical Center

Des Moines, Iowa, United States

Countries

United States

Other Identifiers

MMC2019-46

Identifier Type: -

Identifier Source: org_study_id