Randomised, double-blind crossover study (n=1 actual) comparing a single IV ketamine infusion (0.5 mg/kg) with single IV midazolam (0.045 mg/kg) for acute treatment of bipolar depression.
Randomised, crossover, treatment trial in patients with treatment-resistant bipolar I or II depression evaluating safety and efficacy of a single IV ketamine infusion (0.5 mg/kg) versus active comparator midazolam (0.045 mg/kg) given two weeks apart.
Primary objectives are rapid antidepressant efficacy and safety; key inclusion requires IDS-C30 ≥32 and prior failure of at least three adequate pharmacotherapy trials; participants maintained on divalproex ER and off other psychotropics per protocol.
Crossover sequence: ketamine infusion and midazolam infusion 2 weeks apart; patients randomised to sequence ketamine→midazolam.
Single IV infusion of ketamine 0.5 mg/kg.
Single IV infusion of midazolam 0.045 mg/kg (active comparator).
Crossover sequence: midazolam infusion then ketamine infusion 2 weeks apart; patients randomised to sequence midazolam→ketamine.
Single IV infusion of midazolam 0.045 mg/kg (active comparator).
Single IV infusion of ketamine 0.5 mg/kg.