Randomised, crossover Phase II study (n=1) testing single IV ketamine infusions 0.5 mg/kg and 0.2 mg/kg in postpartum depression to assess safety, pharmacokinetics and antidepressant efficacy.
This randomised, two-period crossover Phase II trial evaluates single intravenous ketamine infusions (0.5 mg/kg and 0.2 mg/kg) in participants with postpartum depression with a 7-day washout between sessions.
Primary objectives are safety and pharmacokinetics; antidepressant efficacy is assessed using standard rating scales (EPDS, HAM-D) with eligibility requiring moderate to severe symptoms and stability of concomitant antidepressant treatment.
Randomised two-period crossover of single IV ketamine infusions (0.5 mg/kg and 0.2 mg/kg) with a 7-day washout; participants receive both doses in counterbalanced order.
Single intravenous infusion 0.5 mg/kg; 7-day washout between sessions
Single intravenous infusion 0.2 mg/kg; 7-day washout between sessions