The study design is a double-blind, randomized, active-control trial of adolescents (ages 13-18 years) with recent suicidal behaviors (suicide attempt or increased suicidal ideation). All participants will be treated through a suicide prevention IOP (typically 6-8 weeks), as well as clinically indicated psychosocial and/or psychopharmacological treatments. Ketamine/midazolam treatment will occur twice weekly during the first two weeks of the study, followed by weekly assessments through week 12.
Randomised, triple-blind, active-controlled Phase III trial in adolescents (13–18 years) with recent suicidal behaviour comparing IV ketamine 0.5 mg/kg versus midazolam 0.02 mg/kg. Four infusions over two weeks with follow-up to 12 weeks.
Primary aims are to evaluate reduction in repeat suicidal events and implicit suicidal cognition with ketamine; secondary outcomes include depressive symptoms, safety, and functional measures. Participants receive standard of care treatment alongside study infusions.
IV ketamine 0.5 mg/kg infused over 40 minutes; four infusions over 2 weeks.
Infused over 40 minutes in 100 ml 0.9% sodium chloride.
IV midazolam 0.02 mg/kg infused over 40 minutes; four infusions over 2 weeks.
Midazolam Hydrochloride (Versed) infused over 40 minutes; active comparator.