This randomised, double-blind, placebo-controlled Phase III trial (n=60) will investigate the efficacy and safety of subcutaneous ketamine (35-70mg/70kg, twice weekly for four weeks) as an add-on treatment for adolescents experiencing a major depressive episode with suicidal ideation and/or behaviour.
Phase III randomised, double-blind, parallel-group trial comparing adjunctive subcutaneous ketamine (0.5–1.0 mg/kg, dose-adjusted) versus active placebo (midazolam 1 mg) given twice weekly for four weeks in adolescents with major depressive episode and active suicidal ideation/behaviour.
Primary efficacy outcomes include depression remission and response (MADRS); safety assessed via adverse event monitoring, clinical examinations and procedure monitoring (continuous and hourly checks for 3 hours post-dose).
Participants continue usual treatment during the trial; randomisation and blinding include participants and outcomes assessors.
Adjunctive subcutaneous ketamine, dose-adjusted 0.5–1.0 mg/kg, twice weekly for 4 weeks.
Subcutaneous injection; dose adjustable 0.5–1.0 mg/kg based on response; 2 sessions/week for 4 weeks; monitored during and 3 h after procedure.
Active placebo comparator: midazolam 1 mg diluted in 5 ml saline, subcutaneous, twice weekly for 4 weeks.
Midazolam 1 mg diluted in 5 ml 0.9% saline; active placebo; subcutaneous administration; monitored during and 3 h after procedure.