Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

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

Randomised, double-blind, placebo-controlled ED trial (n=29) testing a single low-dose IV ketamine infusion (0.5 mg/kg over 40 minutes) for acute depression or suicidal ideation.

Target Enrollment
29 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, quadruple-blind, parallel-group trial compares a single low-dose ketamine infusion (0.5 mg/kg) with placebo in adults presenting to the emergency department with severe depression or suicidal ideation.

Patients are identified at triage or intake, assessed for eligibility, and randomised by computer to ketamine or saline. The study drug is given as a 50 mL IV infusion over 40 minutes with observation and psychiatric reassessment four hours after infusion.

Primary outcomes assess change in depression symptoms during the ED visit and healthcare utilisation after discharge; follow-up contact occurs 30 days after leaving hospital.

Study Protocol

Preparation

0 sessions

Dosing

1 sessions
240 min each

Integration

0 sessions

Study Arms & Interventions

Ketamine

experimental

Single IV infusion of ketamine 0.5 mg/kg in 50 mL 0.9% saline over 40 minutes.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    0.5 mg/kg (Ketalar) in 50 mL 0.9% saline given over 40 minutes; observation and reassessment for 4 hours post-infusion.

Placebo

inactive

Normal saline 0.9% 50 mL IV infusion over 40 minutes.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    0.9% sodium chloride 50 mL IV over 40 minutes (placebo comparator).

Participants

Ages
18 – 99
Sexes
Male & Female

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

Study Details

Locations

MercyOne Des Moines Medical Center — Des Moines, Iowa, United States

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