[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100365920":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":25,"studyPopulation":13,"armGroups":26,"interventions":38,"overallOfficials":45,"centralContacts":49,"locations":55,"responsibleParty":72,"collaborators":13,"id":74,"slug":13,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":13,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":13,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":57,"whyStopped":13,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"VA Connecticut Healthcare System","FED",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Post-traumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)","The five-point CAPS-5 consists of 20 PTSD symptoms rated on a 0-4 scale (total range: 0-80) as follows: (1) 5 Intrusion symptoms (0-20), (2) 2 Avoidance symptoms (0-8), (3) 7 Cognitions and mood symptoms (0-28), and (4) 6 Arousal and reactivity symptoms (0-24). Higher scores represent a worse outcome (i.e., more PTSD symptoms).","1 week",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The current proposal aims to study the pharmacotherapeutic effects of intranasal insulin on PTSD symptoms and inhibition of amygdala hyperactivation in subjects with PTSD.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Intranasal insulin","EXPERIMENTAL","Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).",[32],"Drug: Intranasal insulin",{"label":34,"type":29,"description":35,"interventionNames":36},"Placebo","Subjects in this arm will receive placebo.",[37],"Drug: Placebo",[39,43],{"type":40,"name":28,"description":41,"armGroupLabels":42,"otherNames":13},"DRUG","Subjects in this arm will receive intranasal insulin (80 IU per day).",[28],{"type":40,"name":34,"description":35,"armGroupLabels":44,"otherNames":13},[34],[46],{"name":47,"affiliation":5,"role":48},"Gihyun Yoon, MD","PRINCIPAL_INVESTIGATOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","(203) 932-5711","7421","gihyun.yoon@yale.edu",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","West Haven","Connecticut","06516","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-72.94705,41.27065,{"lat":67,"lon":66},[70],{"name":47,"role":51,"phone":71,"phoneExt":53,"email":54},"203-932-5711",{"type":48,"investigatorFullName":47,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Principal Investigator","100365920",false,"NCT04044534","Intranasal Insulin for Posttraumatic Stress Disorder","Intranasal Insulin for Treating Posttraumatic Stress Disorder","Inclusion Criteria:\n\n* Male or female, 21-65 years old\n* Current PTSD\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Unstable medical condition, clinically determined by a physician\n* Diabetes requiring insulin or oral hypoglycemic agents\n* Moderate-severe traumatic brain injury\n* Current psychotic disorder, bipolar disorder, cognitive disorder in the past 12 months\n* Current substance use disorders (except alcohol, tobacco, or cannabis) in the past 3 months\n* Changes in doses of psychotropic medications in the past 4 weeks\n* Initiation of individual therapy or counseling in the past 4 weeks\n* Imminent suicidal or homicidal risk\n* Contraindication to Insulin\n* History of claustrophobia\n* Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI safety screening questionnaire","ALL","21 Years","65 Years",{"count":84,"type":85},20,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","To evaluate if intranasal insulin is effective in reducing PTSD symptoms.",[91],"PTSD",[28,91],"2025-09-15",{"date":95,"type":96},"2025-09-16","ACTUAL",{"date":98,"type":96},"2024-10-31",{"date":100,"type":85},"2026-05-31",{"name":5,"class":6},1]