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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged 18 years or over.

• Fluent in English.

• 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.

• Have a score on the PTSD Checklist for DSM-5 (PCL-5) equal to or over 33.

Locations
Other Locations
Australia
University of Melbourne
RECRUITING
Carlton
Deakin University
RECRUITING
Geelong
Austin Health
RECRUITING
Heidelberg
Ramsay Clinic Albert Road
RECRUITING
Melbourne
Contact Information
Primary
Greg Roebuck, MD
greg.roebuck@unimelb.edu.au
+61 3 9035 4749
Backup
Georgia Parkin, PhD
georgia.parkin@unimelb.edu.au
+61 3 9035 3417
Time Frame
Start Date: 2024-08-26
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 224
Treatments
Experimental: Silexan 160 mg
Participants in the Silexan arm will take Silexan 160 mg daily in the morning for 12 weeks in addition to their usual prescribed psychoactive medications. Participants will be followed up at 2, 4, 6, 8 and 12 weeks of the intervention period, as well as at 4 weeks post-treatment (off-treatment follow-up period).
Placebo_comparator: Placebo
Participants in this arm will take two placebo capsules daily in the morning for 12 weeks in addition to their usual medications. Participants will be followed up at 2, 4, 6, 8 and 12 weeks of the intervention period, as well as at 4 weeks post-treatment (off-treatment follow-up period).
Related Therapeutic Areas
Sponsors
Collaborators: Ramsay Clinic Albert Road, University of Melbourne
Leads: Deakin University

This content was sourced from clinicaltrials.gov

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