Randomized, open-label, single-blind, non-inferiority Phase IV comparative effectiveness trial (n=1500) comparing ECT versus subanesthetic IV ketamine (0.5 mg/kg) for rapid treatment of acute suicidal depression.
This pragmatic, multi-centre trial randomises adults with acute suicidal major depression to standard electroconvulsive therapy or subanesthetic intravenous ketamine to assess non-inferiority for rapid reduction of suicidal ideation and depressive symptoms.
Ketamine is administered as 0.5 mg/kg IV infusions over 40 minutes twice weekly for up to eight treatments (with a per-dose cap of 60 mg); ECT is delivered three times weekly for up to four weeks using RUL ultra-brief pulse with option to convert to bilateral if required.
Primary outcomes focus on rapid change in suicidal ideation and depression severity; pragmatic design permits clinical dose and treatment modifications per protocol and usual-care procedures.
Subanesthetic IV ketamine 0.5 mg/kg infusion, up to 8 treatments
0.5 mg/kg infusion over 40 minutes; per FDA guidance max 60 mg/dose
Standard ECT three times weekly for up to 4 weeks (RUL ultra-brief pulse, may convert to bilateral)
Right unilateral ultra-brief pulse at ~6x seizure threshold during titration; may change to bilateral if response unsatisfactory; up to 4 weeks of treatment