Phase II randomised, quadruple-blind parallel trial (n=75 actual) of IV ketamine (0.5 mg/kg weekly ×3) vs active placebo (midazolam 0.045 mg/kg) combined with Prolonged Exposure therapy for Veterans with PTSD.
Randomised, quadruple-blind, parallel-group study evaluating IV ketamine 0.5 mg/kg given once weekly for three weeks versus midazolam active placebo, each administered 24–72 hours before Prolonged Exposure (PE) therapy sessions.
Participants are Veterans with PTSD who receive adjunctive infusions plus a course of PE (three infusion-timed PE sessions followed by seven additional PE sessions); outcomes focus on PTSD symptom change and safety/tolerability.
IV ketamine 0.5 mg/kg given 24–72 hrs prior to PE sessions in weeks 1–3, followed by additional PE sessions.
Infusion 24–72 hrs before PE sessions (weeks 1–3).
Active placebo midazolam 0.045 mg/kg IV given 24–72 hrs prior to PE sessions in weeks 1–3, followed by additional PE sessions.
Midazolam (active placebo) administered 24–72 hrs before PE sessions.