An open-label, dose ranging, clinical trial of oral ketamine, an NMDA (N-methyl-D-aspartate) receptor antagonist, with weekly dosing over six weeks in patients who are experiencing post-traumatic stress disorder (PTSD)
This open-label, dose-ranging clinical trial (n=50) aims to determine the feasibility, tolerability, and safety of weekly oral ketamine for PTSD over six weeks with follow-up assessments.
Details
Open-label, single-group Phase I/II study of once-weekly oral sub-anaesthetic ketamine for six weeks (total 6 dosing sessions) in adults with PTSD; dose starts at 0.5 mg/kg with per-session escalation up to 3.0 mg/kg as tolerated.
Primary outcome is change in PTSD symptomatology measured by the PCL-5 between baseline and follow-up 1; a second follow-up occurs 4 weeks after final treatment. Safety and tolerability are monitored throughout.
Doses are administered onsite by study psychiatrist or delegated MHNP with observation up to 2 hours post-dose; accountability logbook and controlled drug register maintained.