STOP Trial

Am I eligible to participate?

To be eligible for the STOP Trial, participants must:*

• Be aged 18 and over
• Have been diagnosed with PTSD or suspect that they have PTSD following a traumatic event
• Currently reside in Australia
• Be an Australian citizen or permanent resident or have a visa status that entitles them to access public mental health services in Australia
• Have good English comprehension
• Not be currently serving in the Australian Defence Force
• Not be pregnant or breastfeeding

Unfortunately, this trial is not suitable for individuals who have been diagnosed with schizophrenia or another psychotic disorder, bipolar disorder or borderline personality disorder. It is also not suitable for individuals with a severe acquired brain injury, moderate or severe alcohol or substance use disorder or active suicidal or homicidal ideation.

*There are additional inclusion and exclusion criteria for the trial. Our intake team will assess prospective participants over the phone to confirm their eligibility.

What will the STOP Trial involve?

Participation involves:

• Taking Silexan or an inactive placebo daily for 12 weeks. Participants will be randomly assigned to Silexan or placebo and will not know which they are taking.
• A baseline assessment with a researcher (2 hours).
• Six further assessments every 2-4 weeks up until week 16 (i.e. 4 weeks post-treatment) (10 minutes to 2 hours).
• Participants can attend assessments in-person at our clinic in Royal Park or online via Zoom.

Eligible participants will be compensated $50 per study assessment that they attend. This compensation may take the form of a gift card.

In order to participate in the trial, participants must consent to the research team communicating with their GP about their participation. Participants are encouraged to share this website with their GP and other health professionals.

For more information about the trial, including possible benefits and risks of participation, please read our Plain Language Statement, here.

How do I refer a client to the STOP trial?

Individuals interested in participating in the trial can self-refer by contacting our intake team on 1800 292 969 or at stop-trial@unimelb.edu.au. They are advised to include ‘The STOP Trial’ in their email.

If you are a health professional who has a client who may be interested in the trial, please provide them with our study flyer and encourage them to contact the intake team: STOP Trial Flyer.

Who is conducting the STOP Trial?

The STOP Trial is sponsored by Deakin University and conducted through Phoenix Australia. Phoenix Australia is a research centre affiliated with the University of Melbourne. It is the National Centre of Excellence in Posttraumatic Mental Health.

This research project has been approved by the Human Research Ethics Committee of The University of Melbourne (ID Number: 29307).