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Current and emerging evidence-based treatments for PTSD have significant limitations. Silexan is an orally administered lavender oil preparation whose main constituents are the monoterpenoids linalool and linalyl acetate. It has a novel pharmacodynamic profile that includes inhibition of voltage-gated calcium channels and promotion of neuroplasticity. Silexan is effective in the treatment of Generalized Anxiety Disorder, subthreshold anxiety disorders and mild-to-moderate Major Depressive Disorder. It has an excellent safety and tolerability profile. Promising pilot data suggest that Silexan may be effective for PTSD. The Silexan in the Treatment Of Posttraumatic stress disorder (STOP) trial aims to investigate the effectiveness of adjunctive Silexan in PTSD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The STOP trial is a 12-week, parallel-arm, randomised, placebo-controlled, double-blind trial. Adults living in Australia who meet diagnostic criteria for PTSD according to the Mini-International Neuropsychiatric Interview-7 and have a score of\u2009\u2265\u200933 on the PTSD Checklist for DSM-5 will be eligible to participate. Participants will have the option of taking part in the trial remotely via videoconferencing software. They will receive either Silexan 160\u00a0mg or an inactive placebo daily for 12\u00a0weeks in addition to their usual prescribed medications. The primary outcome measure will be the change in total symptom severity score on the Clinician-Administered PTSD Scale for DSM-5 from baseline to week 12. Secondary outcome measures will include self-report measures of anxiety symptoms, depressive symptoms, somatic symptoms, sleep quality, subjective wellbeing, quality-of-life and problematic alcohol use. Additional secondary outcome measures will include objective measures of sleep, physical activity and physiology derived from data collected by actigraphy watches. The target sample size will be 278 participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>If Silexan is found to be effective for PTSD, it is likely to be an attractive treatment option for many patients given its favourable safety and tolerability profile. Silexan is already licensed for use in 14 countries, enabling a rapid translation into clinical care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      The STOP trial is registered on the National Institutes of Health clinicaltrials.gov website (ID: NCT06412757, URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT06412757\" ext-link-type=\"uri\">https:\/\/clinicaltrials.gov\/study\/NCT06412757<\/jats:ext-link>\n                      , date of registration: 9 May 2024).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12906-026-05312-7","type":"journal-article","created":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T14:17:28Z","timestamp":1771942648000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Silexan in the Treatment Of Posttraumatic stress disorder (STOP) trial: protocol for a 12-week randomised controlled trial of adjunctive Silexan for PTSD"],"prefix":"10.1186","volume":"26","author":[{"given":"Greg","family":"Roebuck","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgia M.","family":"Parkin,","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meaghan","family":"O\u2019Donnell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rahul","family":"Khanna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Forbes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Winnie","family":"Lau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shae","family":"Serpell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haniya","family":"Al-Azzawi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Santamaria","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammadreza","family":"Mohebbi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravi","family":"Iyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Dean","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard A.","family":"Kanaan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malcolm","family":"Hopwood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica E.","family":"Green","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Berk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,24]]},"reference":[{"key":"5312_CR1","doi-asserted-by":"publisher","first-page":"2260","DOI":"10.1017\/S0033291717000708","volume":"47","author":"KC Koenen","year":"2017","unstructured":"Koenen KC, Ratanatharathorn A, Ng L, et al. 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J Psychiatr Res. 2021;143:572\u20139.","journal-title":"J Psychiatr Res"}],"container-title":["BMC Complementary Medicine and Therapies"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12906-026-05312-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12906-026-05312-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12906-026-05312-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T18:47:46Z","timestamp":1781635666000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s12906-026-05312-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,24]]},"references-count":52,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["5312"],"URL":"https:\/\/doi.org\/10.1186\/s12906-026-05312-7","relation":{},"ISSN":["2662-7671"],"issn-type":[{"value":"2662-7671","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,24]]},"assertion":[{"value":"9 February 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 February 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 February 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The STOP trial received ethical approval from the University of Melbourne Office of Research Ethics and Integrity (OREI) on 18 April 2024 (HREC #29307). The approval from the OREI has been registered with the Deakin University Human Research Ethics Committee, the Ramsay Health Human Research Ethics Committee and the Departments of Defence and Veterans\u2019 Affairs Human Research Ethics Committee. The STOP trial also received ethical approval from the United States Office of Human Research Oversight on 1 August 2024. Protocol amendments approved by OREI are communicated to all listed committees. This protocol aligns with the STOP trial study protocol version 9 (Additional File 1), which was approved by the OREI on 4 December 2025.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"122"}}