[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626128":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":21,"responsibleParty":32,"collaborators":21,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":21,"enrollmentInfo":46,"targetDuration":21,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":21,"overallStatus":55,"whyStopped":21,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":21},{"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",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"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":47,"type":48},32,"ESTIMATED","INTERVENTIONAL",[51],"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",[54],"Inflammatory Bowel Diseases","NOT_YET_RECRUITING","2026-04-30",{"date":58,"type":59},"2026-05-04","ACTUAL",{"date":61,"type":48},"2026-05-01",{"date":63,"type":48},"2027-10-31",{"name":5,"class":6}]