Evaluation of the Efficacy and Safety of Subcutaneous Ketamine in the Treatment of Depressive Episode With Suicidal Ideation and/or Behavior in Adolescents
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.
Details
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.