WIP 65 - Low-Dose Intravenous Ketamine for Adolescents with Depression and Suicidal Ideation in the Emergency Department: A Randomized Double-Blind Placebo-Controlled Trial

Poster Number: WIP 65
Publication Number: WIP 65.2432

Background: Suicide is a leading cause of death among adolescents in the US. Ketamine at sub-dissociative doses has rapid anti-depressant effects among adults in outpatient settings. No data compare sub-dissociative ketamine and placebo in reduction of depression and suicidal ideation (SI) scores among adolescents, especially in the pediatric emergency department (ED).

Objective: To determine the effect of intravenous (IV) ketamine (0.2 mg/kg) on depression and SI scores compared to placebo in adolescents with treatment-resistant depression and acute SI in the ED.

Design/Methods: The university institutional review board approved this randomized, double-blind, placebo-controlled trial. We are enrolling adolescents aged 12-17 years with treatment-resistant depression (failed trials of 2 or more antidepressants for 1 month each) who present to an urban pediatric ED with acute SI requiring inpatient psychiatric care. Exclusion criteria include acute intoxication, primary psychotic disorder, substance use disorder, developmental delay, autism spectrum disorder, aggressive behavior or homicidal ideation, significant cardiac disease or hypertension, allergy or previous adverse reaction to ketamine, pregnancy or breastfeeding, and potential drug interaction. Subjects are randomized in double-blinded fashion to a single dose of ketamine (0.2 mg/kg IV, maximum 35 mg) or saline placebo over 2 minutes. Subjects complete the Beck Depression Inventory (BDI) and Suicidal Ideation Questionnaire (SIQ) at baseline and 1 hour, 3 hours, 1 day, 3 days, and 7 days after receiving the study drug. Upon attainment of a sample of 30 subjects (based on the ability to detect a 60% difference between groups in adequate response, 26 subjects having completed study procedures thus far), we will unblind treatment allocation and compare rates of adequate response (50% reduction in BDI and SIQ) as difference in proportions with 95% confidence intervals and compare reductions in scores using rank-sum test with Hodges-Lehmann estimator.