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

29307

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.

2024-06-01

2027-02-28

2027-03-31

Not yet recruiting

Early phase I

224

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. Lifetime history of a psychotic or bipolar disorder. 2. Moderate or severe alcohol or other substance use disorder within 3 months of screening. 3. Active suicidal or homicidal ideation. 4. Borderline Personality Disorder (BPD). 5. Acute or unstable medical illness or other significant medical condition, including cardiovascular disease, epilepsy and chronic liver or kidney disease. 6. Pregnancy, lactation or unwillingness to use an acceptable method of contraception 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. 7. Commencement of a trauma-focussed psychotherapy (including Prolonged Exposure, Cognitive Processing Therapy and Eye Movement Desensitisation and Reprocessing) within 3 months of screening. 8. Commencement or change in dose of psychoactive medications within 4 weeks of screening. 9. 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. 10. Severe acquired brain injury. 11. Individual is not eligible for public mental health services due to their visa status in Australia or for any other reason. 12. Any other condition that in the opinion of the research team is likely to make completion of the trial requirements infeasible. 13. Inability to understand or speak English to the extent necessary to give informed consent and complete the trial (researcher or clinician-determined).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The trial is a phase 3, 12-week, parallel-arm, randomized, placebo-controlled, double-blind trial. Participants will be randomly allocated to receive either (a) Silexan 160 mg or (b) an identical appearing inert placebo, daily for 12 weeks in addition to their usual prescribed medications.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'All study team members will be blinded to allocation. Blinding will be maintained by ensuring that the packaging, appearance and color of the Silexan (treatment) and placebo capsules are identical. Placebo capsules will also include a sub-therapeutic amount of lavender oil to match the odour of the Silexan capsules. In addition, blinding will be maintained by identifying participants using anonymous participant identifier numbers; an independent statistician will coordinate randomization and an independent pharmacist will store and provide blinded batches to study team members for dispensing.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 224, 'type': 'ESTIMATED'}}

2024-05-16