[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626128":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":32,"responsibleParty":50,"collaborators":21,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":21,"enrollmentInfo":64,"targetDuration":21,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":21,"overallStatus":34,"whyStopped":21,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Duloxetine","EXPERIMENTAL","Duloxetine 30-60 mg daily per oral",[13],"Drug: Duloxetine",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","antidepressant; central neuromodulator",[9],[20],"cymbalta",null,[23,28],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Chung Tse, MD","CONTACT","2153498222","Chung.Tse@Pennmedicine.upenn.edu",{"name":29,"role":25,"phone":30,"phoneExt":21,"email":31},"Maureen DeMarshall, BSN, RN","2153498546","demarshm@pennmedicine.upenn.edu",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-75.16362,39.95238,{"lat":44,"lon":43},[47,48],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},{"name":49,"role":25,"phone":30,"phoneExt":21,"email":31},"Maureen DeMarshall, RN",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Chung Sang Tse","Assistant Professor of Medicine","100626128","phase-2-duloxetine-in-inflammatory-bowel-diseases-100626128",false,"NCT07431606","Duloxetine in Inflammatory Bowel Diseases","A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress","Duloxetine in","Inclusion Criteria:\n\n* Adults over 24 years old; (younger patients are excluded because antidepressants have been shown to increase the risk of suicidal thinking and behavior in patients ≤ 24 years old.)\n* At least one of the following:\n\n  1. elevated psychological distress (Distress Thermometer score \\> 4),10-12\n  2. moderate-to-severe IBD-related disability (IBD-DI score ≥ 356, 7), or\n  3. elevated GI-specific anxiety (Visceral Sensitivity Index \\> 10) -\n\nExclusion Criteria:\n\n* Concomitant use of antidepressants (including serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, buspirone, and thioridazine).\n* Initiation of psychotherapy within 8 weeks.\n* Inability or unwillingness to monitor ambulatory blood pressure and receive a blood pressure monitor via postal mail.\n* Cirrhosis with clinically evident hepatic insufficiency (Child-Pugh Class B or C) by medical record review.1\n* Severe renal impairment (on dialysis; chronic kidney disease stage 4-5; acute kidney injury with glomerular filtration rate \\\u003C30 mL\u002Fminute) by medical record review of labs performed within 18 months.\n* Concurrent participation in another clinical trial of an investigational medicinal product.\n* Pregnant or lactating either by self-report or medical record review\n* Glaucoma\n* Gastroparesis\n* Use of medications that could lead to serious interactions with the study medication: potent CYP1A2 inhibitors, antidepressants (including serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, buspirone, thioridazine), linezolid, intravenous methylene blue, triptans, lithium, fentanyl, tramadol, meperidine, methadone, tryptophan, amphetamines, and St. John's Wort.\n* Bipolar, psychotic, alcohol use disorder, non-alcohol substance-induced disorders, or imminent danger to self or others","ALL","24 Years",{"count":65,"type":66},32,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This open-label, prospective, single-arm pilot study investigates the use of duloxetine, a central neuromodulator, for improving psychological distress and functional impairment in adults with inflammatory bowel disease (IBD). The study focuses on patient-reported outcomes related to anxiety, depression, and IBD-related disability, aiming to assess feasibility, tolerability, and preliminary efficacy in modulating gut-brain axis symptoms and disease-related functional impairments in life",[72],"Inflammatory Bowel Diseases","2026-07-14",{"date":75,"type":76},"2026-07-16","ACTUAL",{"date":78,"type":76},"2026-05-01",{"date":80,"type":66},"2027-10-31",{"name":5,"class":6},1]