Phase II randomised, quadruple-blind trial (n=12 actual) comparing four IV ketamine infusions (0.5 mg/kg each over 40 minutes across two weeks) versus midazolam in adolescents (13–17) with TRD and recent suicide event to assess reduction in suicidal ideation.
Randomised, parallel-group trial testing a conservative repeat-dosing ketamine paradigm (four 0.5 mg/kg IV infusions over two weeks) against an active comparator (midazolam 0.045 mg/kg) in adolescents with treatment-resistant depression and recent suicidal events.
Primary efficacy outcome is suicidal ideation (C-SSRS recent ideation) at 48 hours; participants receive standard of care treatment including medication management and cognitive behavioural therapy and are followed for four months. Functional MRI before and after treatment will be used to identify connectome phenotypes predictive of response.
Midazolam-randomised participants who remain ill may cross-over to open-label ketamine; safety assessments include cardiovascular monitoring, bladder health, and cognitive testing (Cogstate).
Four IV ketamine infusions (0.5 mg/kg) over 40 minutes each across two weeks.
Each infusion administered over 40 minutes.
Four IV midazolam infusions (0.045 mg/kg) over 40 minutes across two weeks; option to cross-over to ketamine for non-responders in open phase.
Midazolam active comparator; non-responders may cross-over to open-label ketamine.