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 oral ketamine for post-traumatic stress disorder (PTSD).

Over a 10-week period, participants will undergo six weeks of active treatment followed by two follow-up assessments. The trial involves administering a sub-anaesthetic dose of ketamine once a week for six weeks, with doses ranging from 0.5mg to 3.0mg per kilogram.

The study will be conducted at the University of the Sunshine Coast Thompson Institute, Australia.

The primary outcome measure will assess PTSD symptomology using the PTSD Checklist for DSM-5 (PCL-5) at various time points, including baseline, pre-ketamine treatment, 24 hours post-ketamine treatment, and follow-up assessments. Secondary outcomes include changes in PTSD symptomology, clinical side effects, suicidality, social and occupational functioning, perceived pleasure, depression, anxiety, stress, global wellbeing, sleep quality, and neurobiological effects.

Participants must be over 18 years old and have a current PTSD diagnosis. Key exclusion criteria include certain psychiatric and physical conditions, history of ketamine use disorder, and pregnancy.

The trial is non-randomised, with recruitment ongoing in Queensland, Australia, with a target sample size of 50 participants. The principal investigator is Dr Adem Can, and the contact person for public and scientific queries is Ms Megan Dutton. Individual participant data sharing is not planned for this trial.

Topic PTSD
Compound Ketamine
Country Australia
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