Silexan in the Treatment Of Posttraumatic Stress Disorder Trial - Trial NCT06412757
Access comprehensive clinical trial information for NCT06412757 through Pure Global AI's free database. This Phase 3 trial is sponsored by Deakin University and is currently Not yet recruiting. The study focuses on Post Traumatic Stress Disorder. Target enrollment is 224 participants.
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Study Focus
Sponsor & Location
Deakin University
Timeline & Enrollment
Phase 3
Jun 01, 2024
Mar 31, 2027
Primary Outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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 224
 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06412757
Non-Device Trial