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

NCT04266288 | Completed Phase 4 FDA Drug

• 1 other identifier: MMC2019-46
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ketamine; Depression; Suicidal Ideation; Emergency Department

Outcome Measures

Primary Outcomes (2)

• Depression Symptom Response

  Patients will be classified as a responder or non-responder, with a response defined as a decrease by 50% or greater for the combined depressive symptom scores of the Brief Psychiatric Rating Scale (BPRS), which includes the following domains: emotional withdrawal, guilt feelings, depressed mood, blunted affect, feelings of inferiority, and suicidal ideation. The total depressive symptom score ranges from 6-42, with a higher score indicating a higher level of severity. Response rate will be compared between the treatment and placebo groups.

  Baseline, 4 hours

• ED Return Visit

  Number of return visits to the emergency department for any psychiatric reason

  30 days from discharge

Secondary Outcomes (4)

• Outpatient follow-up

  30 days from discharge

• Intoxication

  Baseline, 2 hours, 4 hours

• Changes in Individual Psychiatric Symptoms

  Baseline, 4 hours

• Length of stay

  Time from arrival in ED to discharge, either directly from the ED or after inpatient admission. Average length of stay is less than 14 days.

Study Arms (2)

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.

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

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

Drug: Sodium Chloride 0.9%

Interventions

Ketamine DRUG

Active drug

Also known as: Ketalar

Ketamine

Sodium Chloride 0.9% DRUG

Placebo

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MercyOne Des Moines Medical Center: lead

Study Sites (1)

MercyOne Des Moines Medical Center

Des Moines, Iowa, 50314, United States

Location

MeSH Terms

Conditions

Depression; Suicide; Suicidal Ideation; Emergencies

Interventions

Ketamine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kathryn Bress, PharmD

  MercyOne Des Moines Medical Center

  PRINCIPAL INVESTIGATOR

• Adnan Iqbal, MD

  MercyOne Des Moines Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 12, 2020
• Study Start: October 18, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)