[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617243":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":43,"studyPopulation":34,"armGroups":44,"interventions":57,"overallOfficials":34,"centralContacts":67,"locations":73,"responsibleParty":96,"collaborators":98,"id":104,"slug":34,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":34,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":34,"enrollmentInfo":112,"targetDuration":34,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":76,"whyStopped":34,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Oui Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Change in PTSD symptoms between baseline and week 7","Change in PTSD symptoms will be ascertained with the PTSD Checklist for DSM-V (PCL-5). The PCL-5 total score ranges from 0 to 80, with higher scores indicating more severe symptoms.","Baseline, Week 7",[14,17,21,24,27,31],{"measure":15,"description":11,"timeFrame":16},"Change in PTSD symptoms at weeks 15 and 27","Week 15, Week 27",{"measure":18,"description":19,"timeFrame":20},"Change in Anxiety Sensitivity at weeks 7, 15, and 27","Change in Anxiety Sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 total score ranges from 0 to 72 with a higher score indicating greater anxiety sensitivity.","Week 7, Week 15, Week 27",{"measure":22,"description":23,"timeFrame":20},"Change in Generalized Anxiety Disorder at weeks 7, 15, and 27","Change in Generalized Anxiety Disorder will be assessed with the Generalized Anxiety Disorder 7-item (GAD-7) assessment. GAD-7 total score for the seven items ranges from 0 to 21 where a score ranging from 0-4 indicates minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.",{"measure":25,"description":26,"timeFrame":20},"Change in well-being at weeks 7, 15, and 27","Change in well-being will be assessed through the General Life Satisfaction Scale (GLSS). The GLSS total score ranges from 5-35 with higher scores indicating greater life satisfaction.",{"measure":28,"description":29,"timeFrame":30},"Anxiety sensitivity as a mediator of treatment effects on PTSD symptoms at week 3","Anxiety sensitivity will be ascertained with the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 total score ranges from 0 to 72 with a higher score indicating greater anxiety sensitivity.","Week 3",{"measure":32,"description":33,"timeFrame":30},"App usability at week 3","App usability which will be ascertained with the System Usability Scale (SUS). The SUS provides a score from 0 to 100. An average SUS score equal to or greater than 68 is considered usable.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":41},"SINGLE",[42],"PARTICIPANT","The purpose of this study is to conduct a randomized controlled trial to evaluate the efficacy of OTX-601 (intervention) compared to OTX-003 (comparator) in reducing PTSD symptoms from baseline to 7 weeks.",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"OTX-601","EXPERIMENTAL","A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD",[50],"Device: OTX-601 Digital Therapeutic",{"label":52,"type":53,"description":54,"interventionNames":55},"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.",[56],"Device: OTX-003 Comparator app",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":34},"DEVICE","OTX-601 Digital Therapeutic","Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[46],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":34},"OTX-003 Comparator app","Comparator designed to match interface of intervention while providing no active treatment.",[52],[68],{"name":69,"role":70,"phone":71,"phoneExt":34,"email":72},"Brian Keenaghan","CONTACT","203-200-0482","brian@ouitherapeutics.com",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Florida State University","RECRUITING","Tallahassee","Florida","32306","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-84.28073,30.43826,{"lat":86,"lon":85},[89,93],{"name":90,"role":70,"phone":91,"phoneExt":34,"email":92},"Professor of Psychology","850-645-8729","cougle@psy.fsu.edu",{"name":94,"role":95,"phone":34,"phoneExt":34,"email":34},"Jesse Cougle, PhD","PRINCIPAL_INVESTIGATOR",{"type":97,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[99,102],{"name":100,"class":101},"National Institute of Mental Health (NIMH)","NIH",{"name":75,"class":103},"OTHER","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":113,"type":114},40,"ESTIMATED","INTERVENTIONAL",[117],"PHASE2","This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.",[120,121],"PTSD","Post Traumatic Stress Disorder",[120],"2025-12-31",{"date":125,"type":126},"2026-01-05","ACTUAL",{"date":128,"type":126},"2025-12-09",{"date":130,"type":114},"2026-07-31",{"name":5,"class":6},1]