[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617243":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":60,"collaborators":62,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Oui Therapeutics, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OTX-601","EXPERIMENTAL","A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD",[13],"Device: OTX-601 Digital Therapeutic",{"label":15,"type":16,"description":17,"interventionNames":18},"OTX-003","SHAM_COMPARATOR","OTX-003 is a smartphone application developed as a comparator to OTX-601 and designed to match its interface while providing no active PTSD treatment.",[19],"Device: OTX-003 Comparator app",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","OTX-601 Digital Therapeutic","Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"OTX-003 Comparator app","Comparator designed to match interface of intervention while providing no active treatment.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Brian Keenaghan","CONTACT","203-200-0482","brian@ouitherapeutics.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Florida State University","RECRUITING","Tallahassee","Florida","32306","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-84.28073,30.43826,{"lat":50,"lon":49},[53,57],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Professor of Psychology","850-645-8729","cougle@psy.fsu.edu",{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"Jesse Cougle, PhD","PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[63,66],{"name":64,"class":65},"National Institute of Mental Health (NIMH)","NIH",{"name":39,"class":67},"OTHER","100617243","phase-2-determining-the-potential-for-efficacy-of-otx-601-in-reducing-ptsd-symptoms-100617243",false,"NCT07316088","Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms","Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms in a Randomized Controlled Trial (RCT)","Inclusion Criteria:\n\n* Posttraumatic stress disorder (PTSD) diagnosis\n* Anxiety Sensitivity Index 3 (ASI-3) scores above 24\n* PTSD Checklist for DSM-V (PCL-5) scores above 30\n* Understands and speaks English\n* Access to a smartphone that is connected to the internet\n\nExclusion Criteria:\n\n* Score of 24 or lower on the ASI-3\n* Score of 30 and below on the PCL-5\n* No PTSD diagnosis\n* Active psychosis\n* Acute intoxication during study baseline\n* Enrolled in another treatment research study\n* Medical illness that would prevent the completion of interoceptive exposure exercises","ALL","18 Years",{"count":78,"type":79},40,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.",[85,86],"PTSD","Post Traumatic Stress Disorder",[85],"2025-12-31",{"date":90,"type":91},"2026-01-05","ACTUAL",{"date":93,"type":91},"2025-12-09",{"date":95,"type":79},"2026-07-31",{"name":5,"class":6},1]