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The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.","Up to 12 Weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[26,31,34],{"label":27,"type":28,"description":13,"interventionNames":29},"TSND-201, Dose Level 1","EXPERIMENTAL",[30],"Drug: TSND-201",{"label":32,"type":28,"description":13,"interventionNames":33},"TSND-201, Dose Level 2",[30],{"label":35,"type":36,"description":13,"interventionNames":37},"Placebo","PLACEBO_COMPARATOR",[38],"Drug: Placebo",[40,47],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","TSND-201","TSND-201 capsules, given orally, once a week for four consecutive weeks",[27,32],[46],"methylone",{"type":41,"name":35,"description":48,"armGroupLabels":49,"otherNames":13},"Placebo capsules, given orally, once a week for four consecutive weeks",[35],[51],{"name":52,"role":53,"phone":54,"phoneExt":13,"email":55},"Study Director","CONTACT","650-769-6472","amanda@transcendtherapeutics.com",[57,77],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Mountain View Clinical Research","RECRUITING","Denver","Colorado","80209","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-104.9847,39.73915,{"lat":69,"lon":68},[72],{"name":73,"role":53,"phone":74,"phoneExt":75,"email":76},"Brian Johnson","720-941-9363","2","brian@mtnresearch.com",{"facility":78,"status":59,"city":79,"state":80,"zip":81,"country":63,"countryCode":64,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Bradenton Research Center","Bradenton","Florida","34205",{"type":66,"coordinates":83},[84,85],-82.57482,27.49893,{"lat":85,"lon":84},[88],{"name":89,"role":53,"phone":90,"phoneExt":13,"email":91},"Gloria Carlbert, Site Director","941-708-0005","gloriacarlbert@bradentonresearch.com",{"type":93,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100657247","phase-3-an-evaluation-of-the-safety-and-efficacy-of-tsnd-201-for-the-treatment-of-ptsd-100657247",false,"NCT07836647","An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD","EMPOWER-2","Inclusion Criteria:\n\n* Meets DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.\n* Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.\n* Proficient in communication (verbal and reading) to complete interviews and written questionnaires.\n* Free from any other clinically significant illness or disease.\n\nExclusion Criteria:\n\n* Primary diagnosis of any other DSM-5 disorder.\n* Body mass index (BMI) \\\u003C18kg\u002Fm2 or ≥40 kg\u002Fm2.\n* Unable to refrain from nicotine use for at least 8 hours.\n* Use of prohibited concomitant medications or therapies.\n* Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) \u002F cerebrovascular conditions.","ALL","18 Years",{"count":105,"type":106},300,"ESTIMATED","INTERVENTIONAL",[109],"PHASE3","This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. 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