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.

Trial Details

This open-label, dose-ranging clinical trial which aims to determine the feasibility, tolerability, and safety of oral ketamine (OK) for post-traumatic stress disorder. In this 10-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments (week 7; week 10) Participants (N = 50) will be receive a sub-anaesthetic dose of OK once a week over a 6-week period (according to an established titration protocol; 6 ketamine treatments in total); • All participants will be engaged with their treating doctors for the duration of the trial. • Ketamine will be used as an adjunctive treatment, meaning that participants are able to maintain or modify their current treatments under guidance of their physician. Any changes to medication will be recorded by study staff. Primary hypothesis: That a 6-week OK treatment will be efficacious in reducing PTSD symptom frequency and severity. Secondary hypotheses: That a 6-week OK treatment will be efficacious in: reducing stress, anxiety, depression, suicidal ideation; Improving cognitive, social, and occupational functioning; Improving sleep quality; Improving overall wellbeing. Additionally, this study aims to examine the cognitive, neurobiological, and neurophysiological effects of OK treatment in adult participants with PTSD. All changes outlined in this ANZCTR have been approved prior by Princes Charles Hospital Human Research Ethics Committee.

NCT Number ACTRN12618001965291

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.