This double-blinded, randomised controlled trial (n=100) aims to assess the feasibility, tolerability, and safety of intermittent theta burst stimulation (iTBS) and oral ketamine (OK) as a combination treatment for Post-Traumatic Stress Disorder (PTSD).
Randomised, parallel-group, double-blinded Phase II trial comparing active iTBS plus weekly oral ketamine (1 mg/kg, 6 doses) with sham iTBS plus the same ketamine regimen over a 6-week treatment period and 2 follow-ups.
TMS is delivered five days per week (30 sessions total); ketamine is administered on-site once weekly with 2-hour observation. Primary outcome includes PTSD symptom change (PCL-5) between baseline and follow-ups.
Active iTBS plus oral ketamine (OK) over 6 weeks.
Oral ketamine 1 mg/kg once weekly for 6 weeks; observed up to 2 hours post-dose.
iTBS to left DLPFC at 80% RMT; 20 2-second trains per session; session 20–30 minutes including setup.
Sham TMS plus oral ketamine (OK) over 6 weeks.
Oral ketamine 1 mg/kg once weekly for 6 weeks; observed up to 2 hours post-dose.
Sham produces <10% electrical output with auditory/tactile mimicry; session ~20–30 minutes.