Clinical trial of a novel treatment for PTSD | UniSC | University of the Sunshine Coast, Queensland, Australia

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Clinical trial of a novel treatment for PTSD

We conducted a clinical trial investigating if a six-week course of oral ketamine treatment is efficacious in reducing PTSD symptom frequency and severity in adults.

The trial also aims to determine if oral ketamine reduces suicidality, anhedonia, depression and anxiety, and improves sleep quality and social and occupational functioning.

The trial is examining the cognitive, neurobiological, and physiological effects of oral ketamine treatment in adult participants with PTSD.

Participation in this trial is now closed and our research team is analysing outcomes.
Why this study is important

Following the experience of a single or series of traumatic events, some people develop post-traumatic stress disorder (PTSD). PTSD symptoms can disrupt a person's normal activities and ability to function. Although individual symptoms may vary, many display neurological deficits which lead to decreased cognitive and social functioning, behavioral disturbances, sleep difficulties, avoidance of reminders and intrusion of unwanted memories.

Few treatments have been developed which are effective in treating PTSD; even less target the neural dysfunctions caused by PTSD. This study explores an avenue of treatment which previously has been underutilised in PTSD sufferers.

Assessments involved

Participants completed a range of assessments to help us to better understand PTSD and assess treatment response.

  • Clinicial administered and self-report questionnaires
  • Cognitive assessments
  • Medical assessment
  • Brain imaging
  • Electroencephalography (EEG)
  • Blood tests
What is ketamine?

Ketamine belongs to a group of medicines known as anaesthetic agents that, for more than 50 years, have been used to put people to sleep for surgical procedures. . Ketamine has also been used in pain management. It is considered a safe and effective agent when used as an anaesthetic and pain killer, especially in emergency medicine. Ketamine can be given in a variety of ways, such as intravenously, intramuscularly, subcutaneously (ie injection), or orally. Oral ketamine poses advantages in terms of accessibility and cost.

In this clinical trial a sub-anaesthetic dose of oral ketamine was provided.

What is next?

Our research team is analysing outcomes and preparing research papers to share the clinical trial's findings. We look forward to sharing these with you soon.

Participation in this trial has closed.

Prince Charles HREC approval: HREC/18/QPCH/288
Bellberry HREC Approval: 2020-07-653

Other clinical trials for mental health

Read about findings of our clinical trial of a novel treatment for suicidality

Clinician administered and self-report questionnaires <p>A clinical staff member will ask about your mental health, mood, overall wellbeing, day-to-day functioning, and sleep quality. Other demographic information, such as your education level, family history, and support networks will be collected. You will also be asked about your behaviour and experiences following treatment.</p>
Cognitive assessments <p>These are similar to brain games and will assess memory, concentration, attention and reaction time. You will complete cognitive assessments on an iPad.</p>
Medical assessment <p>As part of the medical assessment, you will be asked questions about your medical history and your family’s medical history. Biomedical measurements, such as height, weight and blood pressure will also be taken. You will be asked to provide regular urinary samples to assess for elevations in enzymes and pregnancy.</p>
Brain imaging <p>Magnetic resonance imaging (MRI) is a non-invasive form of brain imaging which utilises the natural magnetic properties of water molecules to generate signal and therefore build up a 3D map of all the different tissues within the body. These scans are capable of assessing structural, functional, and chemical changes in the brain. As part of this protocol, you will be asked to complete a cognitive task in the MRI.</p>
Electroencephalography (EEG) <p>EEG is a non-invasive way of measuring brain activity. You will be asked to wear a headcap containing sensors that record the electrical activity generated by your brain. A water-based gel will be placed in your hair to assist the connection between the sensors on the cap and your scalp. This assessment will involve short computerised resting tasks which will be conducted while your brain activity is recorded.</p> <p class="footnote"> </p>
Blood tests <p>You will be asked to undergo five blood tests, which will be collected at a nearby pathology center. These samples will be used to ensure your safety and eligibility within this trial. These samples will also be used to assess molecular biological brain changes</p>