[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07316088":3,"trial-entities:NCT07316088":103,"trial-summary:NCT07316088":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":67,"minimum_age":68,"maximum_age":15,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":86,"locations":89,"central_contacts":99,"overall_officials":100,"references":101,"see_also_links":102},"NCT07316088","2024-Oui-002-Study2","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)","ACTIVE_NOT_RECRUITING","2026-08-17","2026-07","2026-07-15","2025-12-09","Oui Therapeutics, Inc.","INDUSTRY",null,"This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.","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.",[19,20],"PTSD","Post Traumatic Stress Disorder",[19],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},40,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","OTX-601 Digital Therapeutic","Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[35],"OTX-601",{"type":31,"name":37,"description":38,"armGroupLabels":39},"OTX-003 Comparator app","Comparator designed to match interface of intervention while providing no active treatment.",[40],"OTX-003",[42],{"measure":43,"description":44,"timeFrame":45},"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",[47,50,54,57,60,64],{"measure":48,"description":44,"timeFrame":49},"Change in PTSD symptoms at weeks 15 and 27","Week 15, Week 27",{"measure":51,"description":52,"timeFrame":53},"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":55,"description":56,"timeFrame":53},"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":58,"description":59,"timeFrame":53},"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":61,"description":62,"timeFrame":63},"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":65,"description":66,"timeFrame":63},"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.","ALL","18 Years",false,{"inclusion":71,"exclusion":77,"raw_text":85},[72,73,74,75,76],"Posttraumatic stress disorder (PTSD) diagnosis","Anxiety Sensitivity Index 3 (ASI-3) scores above 24","PTSD Checklist for DSM-V (PCL-5) scores above 30","Understands and speaks English","Access to a smartphone that is connected to the internet",[78,79,80,81,82,83,84],"Score of 24 or lower on the ASI-3","Score of 30 and below on the PCL-5","No PTSD diagnosis","Active psychosis","Acute intoxication during study baseline","Enrolled in another treatment research study","Medical illness that would prevent the completion of interoceptive exposure exercises","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",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":91,"city":92,"state":93,"zip":94,"country":95,"geoPoint":96},"Florida State University","Tallahassee","Florida","32306","United States",{"lat":97,"lon":98},30.43826,-84.28073,[],[],[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":69,"summary":15,"prompt_version":15}]