Suicide is one of the leading causes of death among adolescents in the United States. The 'Acute Course of Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents' (TASK), a double-blind, randomized, controlled trial, was designed to examine the signal for efficacy of ketamine, compared to midazolam (active control), in reducing 1) repeat suicidal events, 2) implicit cognition, and 3) depression symptoms and suicidal thoughts and behaviors in adolescents (ages 13-18 years) with recent suicidal events. The report describes the study rationale and design, and the baseline cohort characteristics. Participants were randomized (1:1) to receive either intravenous ketamine (0.5 mg/kg) or midazolam (0.02 mg/kg) for four infusions during the first two weeks (days 0, 3, 7, 10). Participants completed follow-up assessment visits weekly through week 12 (twice weekly during the first two weeks) to monitor outcomes. Of the 70 participants who consented/assented to screening, 55 were deemed eligible, and 50 were randomized to ketamine or midazolam. The participants were 82% female and 64% White, with a mean age of 15.4 years (SD = 1.6). On average, the adolescents had three lifetime suicide attempts (SD = 2), two inpatient hospitalizations for lifetime suicidal ideation (SD = 2), and one lifetime emergency evaluation for suicidal ideation (SD = 1). Approximately three out of four youth (74%) reported moderate to severe depression, and 54% reported moderate to severe anxiety. TASK study findings may inform the use of ketamine to reduce suicidal events in youths with recent suicidal events. Clinical Trial Registration: The trial is registered with ClinicalTrials.gov (NCT04592809; date of registration - 10.19.2020).
