Using Silexan to treat Posttraumatic Stress Disorder

Silexan in the Treatment Of Posttraumatic Stress Disorder (STOP) Trial

This study is testing if Silexan, a treatment made from lavender oil, can help people with Posttraumatic Stress Disorder feel better compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Deakin University (Academic / other)
• Locations: 4 sites (Carlton, Victoria and 3 other locations)
• Trial ID: NCT06412757 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Silexan, a lavender oil-derived treatment, for individuals diagnosed with Posttraumatic Stress Disorder (PTSD). The study aims to address the limitations of current PTSD treatments, such as psychotherapy and antidepressant medications, which often have low efficacy and significant side effects. Participants will be randomly assigned to receive either Silexan or a placebo, and their PTSD symptoms will be assessed using standardized measures. The trial seeks to determine if Silexan can provide a well-tolerated and effective alternative for those suffering from PTSD.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and over who meet the DSM-5 criteria for PTSD and have a specific severity of symptoms.

Not a fit: Patients with a history of severe psychiatric disorders, substance use disorders, or those currently serving in the military may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients with PTSD who struggle with existing therapies.

How similar studies have performed: Previous studies have shown Silexan to be effective for anxiety disorders, suggesting potential for success in treating PTSD, although this specific application is novel.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 years or over.
2. Fluent in English.
3. Meet DSM-5 criteria for PTSD, irrespective of occupation (e.g. first responder, police officer, ex-military or civilian), determined using the Mini International Neuropsychiatric Interview 7.0.2.
4. Have a score on the PTSD Checklist for DSM-5 (PCL-5) equal to or over 33.

Exclusion Criteria:

1. Are currently serving in the Australian Defence Force
2. Lifetime history of a psychotic or bipolar disorder, or dissociative identity disorder.
3. Moderate or severe alcohol or other substance use disorder within 3 months of screening.
4. Active suicidal or homicidal ideation.
5. Borderline Personality Disorder (BPD).
6. Acute or unstable medical illness or other significant medical condition, that would make participation in the trial unsafe or inappropriate.
7. Pregnancy, lactation or unwillingness to use an acceptable method of contraception (required for both males and females who are of reproductive potential and sexually active with partners of the opposite sex) through the duration of participants' involvement in the study up to and including week 16. Participants will also be advised not to donate eggs or sperm during the study period.
8. Commencement of a trauma-focussed psychotherapy (including Prolonged Exposure, Cognitive Processing Therapy and Eye Movement Desensitisation and Reprocessing) within 3 months of screening.
9. Commencement or change in dose of psychoactive medications within 4 weeks of screening.
10. Participants will be asked not to initiate psychotherapy or change the dose of psychoactive medications during the course of the study except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the participant or terminating their participation.
11. Severe acquired brain injury.
12. Individual is not eligible for public mental health services due to their visa status in Australia or for any other reason.
13. Any other condition that in the opinion of the research team is likely to make completion of the trial requirements infeasible.
14. Inability to understand or speak English to the extent necessary to give informed consent and complete the trial (researcher or clinician-determined).

Where this trial is running

Carlton, Victoria and 3 other locations

• University of Melbourne — Carlton, Victoria, Australia (Recruiting)
• Deakin University — Geelong, Victoria, Australia (Recruiting)
• Austin Health — Heidelberg, Victoria, Australia (Recruiting)
• Ramsay Clinic Albert Road — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Principal investigator: Michael Berk, PhD — Deakin University
• Study coordinator: Greg Roebuck, MD

Conditions Post Traumatic Stress Disorder; posttraumatic stress disorder; adjunctive treatment; Silexan; phytoceutical; pharmacotherapy; randomized controlled trial