Randomised, quadruple-blind, parallel-group pilot trial (n=25) of four once-weekly IV ketamine infusions (0.05 mg/kg) versus midazolam infusions (0.045 mg/kg) as adjunctive treatment for inpatients with acute depressive episodes to assess trial processes and preliminary outcomes.
Pragmatic, randomised, controlled, parallel-group pilot trial enrolling inpatients admitted to St Patrick's University Hospital for an acute depressive episode; participants were randomised 1:1 to ketamine or midazolam.
Intervention comprised four once-weekly sub-anaesthetic IV infusions (ketamine 0.05 mg/kg or midazolam 0.045 mg/kg) administered by a consultant anaesthetist; both participants and assessors were blinded.
Outcomes included physical, psychotomimetic and cognitive measures collected before, during and after infusions; blood samples were taken at four time-points during the first infusion and before the final infusion for neuroplasticity biomarker studies, with follow-up over three months.
Four once-weekly sub-anaesthetic ketamine infusions administered by a consultant anaesthetist.
Four once-weekly infusions; blood sampling at four time-points during first infusion and before final infusion for biomarker studies.
Four once-weekly sub-anaesthetic midazolam infusions administered by a consultant anaesthetist.
Midazolam 0.045 mg/kg (active comparator; recorded as compoundReport.placebo with name in notes).