Randomised, quadruple-blind, parallel Phase II trial (n=40) comparing IV ketamine 0.5 mg/kg vs midazolam 0.045 mg/kg twice weekly for 3 weeks in Veterans with mild–moderate TBI and comorbid PTSD and MDD to evaluate efficacy and safety.
This parallel, randomised, quadruple-blind Phase II study will compare racemic IV ketamine 0.5 mg/kg to active comparator midazolam 0.045 mg/kg administered twice weekly for three weeks (six 40-minute infusions) in Veterans with chronic mild–moderate traumatic brain injury and comorbid PTSD and major depressive disorder.
Outcomes include change in PTSD and depression symptom scales, safety and tolerability in the TBI population, laboratory tests, interviews, and standard questionnaires assessed during treatment and follow-up.
IV ketamine 0.5 mg/kg twice weekly for 3 weeks (6 infusions).
Infusion over 40 minutes
IV midazolam 0.045 mg/kg twice weekly for 3 weeks (6 infusions).
Midazolam 0.045 mg/kg IV infusion over 40 minutes (active comparator)