Pragmatic, randomised, controlled, parallel-group pilot (n=24 planned; 3 actual) of twice-weekly ketamine (0.5 mg/kg) vs midazolam (0.045 mg/kg) infusions interleaved with ECT for a major depressive episode to assess trial processes for a future definitive trial.
Pragmatic randomised parallel-group pilot comparing twice-weekly sub-anaesthetic ketamine infusions (0.5 mg/kg) with midazolam (0.045 mg/kg) as adjuncts to an ECT course; infusions administered by a consultant anaesthetist with first infusion after the first or second ECT.
Outcomes include physical, psychotomimetic and cognitive measures assessed during and after infusions, with follow-up at six weeks and three months to assess relapse; treatment-as-usual continued throughout.
Twice-weekly ketamine infusions given adjunctive to ECT; administered by consultant anaesthetist; first infusion after first or second ECT.
Sub-anaesthetic infusion; administered by consultant anaesthetist; given during ECT course.
Twice-weekly midazolam infusions given adjunctive to ECT; administered by consultant anaesthetist.
Midazolam 0.045 mg/kg (Hyponovel); active comparator; administered by consultant anaesthetist.