Enhancing Week-long Psychological Treatment for PTSD With Ketamine
Randomised, parallel Phase II trial (n=162) comparing two ketamine IV doses (0.2 mg/kg and 0.5 mg/kg; two infusions) vs midazolam (active comparator) combined with week-long trauma-focused psychotherapy for chronic PTSD.
Details
This parallel-group, randomised Phase II trial evaluates whether combining two IV ketamine infusions with intensive trauma-focused psychotherapy over one week produces greater PTSD symptom reduction than midazolam plus the same psychotherapy.
Participants receive psychotherapy education at the first visit, an infusion and MRI on day 2, psychotherapy sessions on days 3–6 (60–90 minutes each), a second infusion on day 4, and a post-treatment MRI on day 7; follow-up clinical assessments and one MRI at 30 days and clinical evaluation at 90 days assess durability.
Outcomes include PTSD symptom measures (CAPS-5), safety/tolerability, and neurophysiological changes on MRI to explore mechanistic effects of drug-augmented psychotherapy.