Actively Recruiting
Silexan in the Treatment Of Posttraumatic Stress Disorder Trial
Led by Deakin University · Updated on 2025-12-18
278
Participants Needed
4
Research Sites
144 weeks
Total Duration
On this page
Sponsors
D
Deakin University
Lead Sponsor
U
University of Melbourne
Collaborating Sponsor
AI-Summary
What this Trial Is About
Posttraumatic stress disorder (PTSD) is a common and debilitating mental illness. Current treatments for PTSD include psychotherapy and antidepressant medications. Many patients are unable to tolerate psychotherapy for PTSD and drop out of it. In addition, its effectiveness is limited. Up to 50 percent of patients who receive psychotherapy do not benefit from it. Antidepressant medications have only small benefits in PTSD. They also have unpleasant side effects that can make patients unwilling to take them. There is an urgent need to develop new treatments for PTSD that work and are well-tolerated. Silexan has the potential to provide an important alternative treatment for PTSD. Silexan is derived from lavender oil. It is taken orally in the form of capsules. It is currently available over-the-counter in 14 countries, including Australia and the United States. Previous research has shown that it is an effective treatment for anxiety disorders, including Generalized Anxiety Disorder. It is also well-tolerated by patients. The only side effects that have been identified so far are mild gastrointestinal symptoms (including burping and breath odour) and these are uncommon. The results of a small pilot study suggest that Silexan may also be effective and well-tolerated in PTSD. The STOP trial is a clinical trial that aims to investigate whether adding Silexan to treatment-as-usual improves PTSD symptoms in adults with PTSD. The trial will recruit 278 participants. Participants will be randomly assigned to take Silexan or a placebo (look-alike dummy pills) daily in addition to their usual medications for 12 weeks. The severity of their PTSD symptoms will be assessed prior to and at the end of this 12-week period. The STOP trial has the potential to obtain definitive evidence regarding whether Silexan helps treat symptoms of PTSD. If Silexan is found to be an effective treatment for PTSD, the pool of patients who could potentially benefit from this treatment includes any adults with PTSD. Silexan is already available over-the-counter at a relatively low cost so there will be few barriers to accessing this treatment.
CONDITIONS
Official Title
Silexan in the Treatment Of Posttraumatic Stress Disorder Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or over
- Fluent in English
- Meet DSM-5 criteria for PTSD, determined using the Mini International Neuropsychiatric Interview 7.0.2
- Have a score of 33 or higher on the PTSD Checklist for DSM-5 (PCL-5)
You will not qualify if you...
- Currently serving in the Australian Defence Force
- History of psychotic or bipolar disorder, or dissociative identity disorder
- Moderate or severe alcohol or substance use disorder within 3 months of screening
- Active suicidal or homicidal thoughts
- Borderline Personality Disorder
- Acute or unstable medical illness or other significant medical condition unsafe for trial participation
- Pregnancy, lactation, or unwillingness to use contraception during study up to week 16
- Started trauma-focused psychotherapy within 3 months of screening
- Started or changed dose of psychoactive medications within 4 weeks of screening
- Severe acquired brain injury
- Ineligible for public mental health services due to visa status or other reasons
- Any condition making trial completion infeasible
- Inability to understand or speak English sufficiently to consent and complete the trial
AI-Screening
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Trial Site Locations
Total: 4 locations
1
University of Melbourne
Carlton, Victoria, Australia, 5053
Actively Recruiting
2
Deakin University
Geelong, Victoria, Australia, 3220
Actively Recruiting
3
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
4
Ramsay Clinic Albert Road
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
G
Greg Roebuck, MD
CONTACT
G
Georgia Parkin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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