Silexan in the Treatment Of Posttraumatic Stress Disorder Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Silexan: Participants in the Silexan arm will take two over-encapsulated capsules, each containing 80 mg Silexan, daily orally in the morning in addition to their usual medications. No modifications of allocated interventions will be made for any trial participants; if appropriate (i.e following the emergence of adverse events) participants will be withdrawn from the intervention.

Placebo: Participants in the placebo arm will take two capsules containing an inert placebo daily orally in the morning in addition to their usual medications. The placebo capsules will contain a sub-therapeutic amount of lavender oil to mimic the odor of the experimental drug (Silexan).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) — At baseline and at week 12 of the study period
  The Primary Outcome Measure will be the between-group difference in the change from baseline to week 12 in the total symptom severity score on the CAPS-5. The CAPS-5 has good internal consistency, inter-rater reliability, test-retest reliability and convergent validity in measuring PTSD symptom severity, and is regarded as the gold-standard for measuring PTSD symptoms in research settings. The CAPS-5 will be used to query the presence of PTSD symptoms across the two weeks prior to each CAPS-5 assessment. We will also compare between-group differences in remission rates of PTSD, as determined by the CAPS-5.

Trial sites (4)

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