[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Deakin University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100547806","phase-3-silexan-in-the-treatment-of-posttraumatic-stress-disorder-trial-100547806",false,"NCT06412757","Silexan in the Treatment Of Posttraumatic Stress Disorder Trial","Silexan in the Treatment Of Posttraumatic Stress Disorder (STOP) Trial","STOP","Inclusion Criteria:\n\n1. Aged 18 years or over.\n2. Fluent in English.\n3. 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.\n4. Have a score on the PTSD Checklist for DSM-5 (PCL-5) equal to or over 33.\n\nExclusion Criteria:\n\n1. Are currently serving in the Australian Defence Force\n2. Lifetime history of a psychotic or bipolar disorder, or dissociative identity disorder.\n3. Moderate or severe alcohol or other substance use disorder within 3 months of screening.\n4. Active suicidal or homicidal ideation.\n5. Borderline Personality Disorder (BPD).\n6. Acute or unstable medical illness or other significant medical condition, that would make participation in the trial unsafe or inappropriate.\n7. 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.\n8. Commencement of a trauma-focussed psychotherapy (including Prolonged Exposure, Cognitive Processing Therapy and Eye Movement Desensitisation and Reprocessing) within 3 months of screening.\n9. Commencement or change in dose of psychoactive medications within 4 weeks of screening.\n10. 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.\n11. Severe acquired brain injury.\n12. Individual is not eligible for public mental health services due to their visa status in Australia or for any other reason.\n13. Any other condition that in the opinion of the research team is likely to make completion of the trial requirements infeasible.\n14. Inability to understand or speak English to the extent necessary to give informed consent and complete the trial (researcher or clinician-determined).","ALL","18 Years",{"count":20,"type":21},278,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.\n\nSilexan 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.\n\nThe 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.\n\nThe 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.",[27],"Post Traumatic Stress Disorder",[29,30,31,32,33,34],"posttraumatic stress disorder","adjunctive treatment","Silexan","phytoceutical","pharmacotherapy","randomized controlled trial","RECRUITING","2025-12-10",{"date":38,"type":39},"2025-12-18","ACTUAL",{"date":41,"type":39},"2024-08-26",{"date":43,"type":21},"2027-06",{"name":45,"class":46},"Deakin University","OTHER",4,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100602658","the-family-foundations-trial-100602658","NCT07126379","The Family Foundations Trial","The Family Foundations Trial: Promoting Family Wellbeing in Regional and Rural Communities Affected by Environmental Threats","Inclusion Criteria:\n\n* Family must be living in a regional or rural area\n* Family must have at least one child aged 0-12 years\n* At least 2 parents\u002Fcaregivers in the family must agree to participate in evaluation, and FF, if allocated. (Please note: A family member or someone else involved in raising children in the family may participate in FF. Families are not required to be in a couple relationship or living together).\n* At least one parent\u002Fcaregiver within the family reports mental health difficulties and\u002For two or more risk factors for poor mental health in the last 5 years including (a) experienced a recent or past natural disaster (i.e., drought, flood, fire, severe storm), (b) living with the threat of a natural disaster (i.e., bushfires during summer), (c) self-reported history of poor mental health, (d) financial hardship, (e) young parental age at time of first baby (18-25yrs), (f) relationship conflict, or (g) social isolation.\n\nExclusion Criteria:\n\n* At least one parent has a severe mental health disorder - self reported psychosis, substance use dependency, prescribed anti-psychotic medication that may interfere with their ability to take part in the trial and in the FF intervention if allocated. They may require more intensive mental health interventions and treatment than what can be provided by the trial interventions.\n* The family has an overt indicator of family violence - self-reported intervention order or court case for family violence.\n* The family has child protection service involvement - self-reported.",true,{"count":57,"type":21},472,[59],"NA","In this project, researchers are exploring different ways to support the wellbeing and relationships of families with young children (0-12 years). People in regional and rural communities often live with the threat of bushfires, floods, drought, severe storms, and other extreme weather events. Some families have been affected by these disasters and are still trying to recover.\n\nResearchers will test two different ways of supporting families in regional and rural Victoria:\n\nFamily Foundations (FF): An 8-session program to promote parent wellbeing, parenting partnerships, and communication. All parents\u002Fcaregivers\u002Fparenting partners in the family participate in sessions delivered by a health professional online.\n\nFamily Life Check-In: A brief 30-minute telephone call with a health professional to discuss family wellbeing and relationships, and identify any supports needed.\n\nThe goal of this trial is to learn whether FF works to reduce mental health difficulties for regional and rural families. The main question it aims to answer is:\n\nCompared to Family Life Check-In, does Family Foundations lead to fewer mental health difficulties?\n\nParticipants will:\n\nComplete an online survey before randomisation, after they have received FF or Family Life Check-In, and six months after starting the project.\n\nTake part in either Family Foundations or Family Life Check-In.",[62],"Mental Health Outcomes",[64,65,66,67],"mental health","parent mental health","coparenting","rural health","NOT_YET_RECRUITING","2025-08-13",{"date":71,"type":39},"2025-08-17",{"date":73,"type":21},"2025-10-01",{"date":75,"type":21},"2027-08-01",{"name":45,"class":46},6,""]