Double-blind, randomised, parallel-group trial (n=48) comparing a single 0.5 mg/kg ketamine infusion versus active placebo midazolam 0.045 mg/kg in adults with treatment-resistant depression to assess antidepressant and antisuicidal effects.
This double-blind, randomised, parallel-group study in Taiwan enrols 48 adults with treatment-resistant major depression to compare a single subanaesthetic ketamine infusion (0.5 mg/kg) with an active midazolam placebo (0.045 mg/kg).
Primary outcomes are antidepressant response by MADRS and HAMD ratings and changes in suicide-related symptoms; assessments are conducted from baseline through 14 days post-infusion. The trial builds on prior evidence of rapid antidepressant and antisuicidal effects of ketamine and seeks to validate these effects in a Han Chinese population.
Single subanaesthetic ketamine infusion 0.5 mg/kg for TRD.
Single subanaesthetic infusion (0.5 mg/kg).
Active placebo midazolam 0.045 mg/kg.
Active placebo: midazolam 0.045 mg/kg (Dormicum).