Randomised, double-blind, parallel-group trial (n=12 actual) testing IV low-dose ketamine 0.5 mg/kg versus active placebo (midazolam 0.045 mg/kg) in adolescents (13–19) with treatment-resistant depression.
Rationale: adolescent treatment-resistant depression is common and associated with high suicidal risk; low-dose ketamine has rapid antidepressant effects in adults and is being evaluated here in adolescents.
Design: randomised, double-blind, parallel-group trial comparing active placebo midazolam (0.045 mg/kg) and ketamine (0.5 mg/kg) across two infusion sessions (Day 1 and Day 3); primary purpose is treatment.
Outcomes and population: efficacy and safety in adolescents aged 13–19 with TRD, with clinical assessments and follow-up per protocol; actual registry count indicates 12 participants to date.
Two 0.045 mg/kg midazolam infusions (active placebo) on Day 1 and Day 3.
Two 0.045 mg/kg infusions on Day 1 and Day 3 (active placebo).
First 0.045 mg/kg midazolam infusion and second 0.5 mg/kg ketamine infusion (crossover of infusions across sessions).
Day 1: midazolam 0.045 mg/kg.
Day 3: ketamine 0.5 mg/kg.
Two 0.5 mg/kg ketamine infusions.
Two 0.5 mg/kg infusions (Day 1 and Day 3).