Research Study Name: Silexan in the Treatment Of Posttraumatic Stress Disorder (STOP) Trial
Research Centre: Deakin University and the University of Melbourne

Are you or someone you know struggling with PTSD? This study might offer a beacon of hope. It is a trial of Silexan, a lavender oil medication, for PTSD. Study participants will take Silexan or a placebo daily for 12 weeks in addition to their usual medications. Their PTSD symptoms will be measured by the research team over seven study visits. Participants can attend these visits in person or via videoconferencing (Zoom). They will receive $50 per visit for participating in the study.

Study Location: Phoenix Australia Traumatic Stress Clinic, Parkville, Australia, or remotely (online)
Lead Researchers: Prof. Michael Berk, Dr. Greg Roebuck, Prof. Meaghan O’Donnell, Prof. David Forbes, Prof. Richard Kanaan, Dr. Rahul Khanna, Dr. Mohammadreza Mohebbi, Prof. Malcolm Hopwood, and Ass. Prof. Olivia Dean
IRB and HREC: This study has been reviewed and approved by the OHRO Institutional Review Board and the University of Melbourne Human Research Ethics Committee

The STOP trial is It’s conducted by Deakin University and the University of Melbourne and aims to provide evidence on the effectiveness of Silexan in treating adult PTSD. Silexan is an oral medication containing lavender oil, an essential oil derived from the lavender plant. It is available over-the-counter in Australia and is already used to treat anxiety conditions, including Generalized Anxiety Disorder. There is evidence suggesting that it may also be effective in PTSD.

This study could potentially revolutionize PTSD care by offering a safe, affordable, and readily available solution. With the current limitations of existing treatments, Silexan presents an opportunity to address a significant gap in mental health care for individuals suffering from PTSD. By participating, you can contribute to groundbreaking research that may improve outcomes for countless others facing similar challenges. If you’re interested in learning more or joining this study, take our online questionnaire and advance medical research.

• Participants may receive Silexan for PTSD at no cost. This medication is adjunctive, which means that patients will continue their usual medications and can keep seeing their usual psychologist or counsellor during the trial.
• Participants will receive $50 for each of the seven study assessments that they attend in person or virtually. Reimbursement will only be provided to eligible participants who complete each study visit.
• Participants can choose to participate in the study virtually with the trial medication mailed to them. it is not necessary for them to physically attend the Phoenix Australia clinic.
• Participants may experience improvements in their PTSD symptoms. 
• Participants will be contributing valuable information that may benefit those with PTSD in the future.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Adults who meet the study criteria for Post-Traumatic Stress Disorder (PTSD)
• Must be fluent in English
• Must not have commenced or plan to commence trauma-focused psychotherapy (e.g. Prolonged Exposure, Cognitive Processing Therapy, Eye Movement Desensitization and Reprocessing) within 3 months of screening
• Must not have a lifetime history of psychotic or bipolar disorder
• Must not have borderline personality disorder
• Must not have started taking or changed the dose of a psychoactive medication within 4 weeks of screening
• Must not have a severe brain injury
• Must not have moderate or severe alcohol or substance use disorder within the past 3 months
• Must be able and willing to participate in the study for approximately 16 weeks

The study team will explain the research in its entirety but some details are:

• Participants will take Silexan 160 mg or an inactive placebo daily for 12 weeks.
• Participants will undergo a randomised double-blind study, meaning they have an equal chance of receiving either Silexan or placebo capsules and will not know which capsules they are receiving.
• Participants will be asked to refrain from starting a new course of psychotherapy or starting a new psychoactive medication (or adjusting the dose of an existing psychoactive medication) during the trial, except in urgent cases (where decisions will be made on a case-by-case basis regarding the participant’s continued participation in the trial).
• Participants will attend scheduled assessments, including a baseline visit, as well as visits on weeks 2, 4, 6, 8, 12, and 16 of the study period, with the option to attend in person or virtually. During these assessments, participants will provide health updates and complete questionnaires, with most assessments lasting up to one hour, except for baseline, week 12 and week 16 assessments, which may extend to 2 hours.

Research Centres
This trial is a collaboration between the Institute for Mental and Physical Health and Clinical Translation (IMPACT) at Deakin University, Phoenix Australia (which is affiliated with the University of Melbourne), Austin Health, and the Ramsay Clinic Albert Road. Screening and study assessments will be conducted by Phoenix Australia, which is a research centre with specialist expertise in trauma-related mental health and wellbeing. For over 25 years, Phoenix Australia has been Australia’s National Centre of Excellence in Posttraumatic Mental Health and internationally recognised leaders in the field. Phoenix Australia is committed to driving forward the mental health agenda both at home and abroad.