[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07431606":3,"trial-entities:NCT07431606":111,"trial-summary:NCT07431606":115},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":41,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":72,"locations":75,"central_contacts":94,"overall_officials":98,"references":99,"see_also_links":110},"NCT07431606","859508","Duloxetine in Inflammatory Bowel Diseases","A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress","RECRUITING","2027-10-31","2026-02","2026-07-16","2026-05-01","University of Pennsylvania","OTHER",true,"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","Subjects will be screened and enrolled once PI confirms eligibility. After patient signs consent:\n\nDuloxetine 30 mg orally daily will be administered for 1 week (age \\\u003C65 years) or 2 weeks (age ≥65 years), then increased to duloxetine 60 mg orally daily, if tolerated.\n\nPatients may continue duloxetine 30 mg if they do not tolerate duloxetine 60 mg.\n\nPatients will receive 30-60 mg of duloxetine for 6 weeks, followed by a tapering period of 2 weeks at the end of treatment, mailed to their home address. Patients who wish to continue taking duloxetine after the trial may contact their primary care provider to obtain a prescription for duloxetine.\n\nPatient reported outcomes will be completed at set intervals.",[19],"Inflammatory Bowel Diseases",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},32,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Duloxetine","antidepressant; central neuromodulator",[31],[35],"cymbalta",[37],{"measure":38,"description":39,"timeFrame":40},"Change in IBD-related disability","IBD Disability Index scores, range 0-100, higher score indicates more disability","6 weeks",[42,45,48],{"measure":43,"description":44,"timeFrame":40},"Changes in psychological distress","Depression Anxiety and Stress Scale (DASS-21), range 0-21, higher scores indicate higher distress Distress Thermometer, range 0-10, higher scores indicate higher distress",{"measure":46,"description":47,"timeFrame":40},"Tolerability and safety","Determine the tolerability and safety of duloxetine (30-60 mg daily)",{"measure":49,"description":50,"timeFrame":40},"Changes in gastrointestinal-specific anxiety","Visceral Sensitivity Index (VSI), range 0-75, higher scores indicate more gastrointestinal-specific anxiety","ALL","24 Years",null,false,{"inclusion":56,"exclusion":59,"raw_text":71},[57,58],"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.)","At least one of the following:",[60,61,62,63,64,65,66,67,68,69,70],"Concomitant use of antidepressants (including serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, buspirone, and thioridazine).","Initiation of psychotherapy within 8 weeks.","Inability or unwillingness to monitor ambulatory blood pressure and receive a blood pressure monitor via postal mail.","Cirrhosis with clinically evident hepatic insufficiency (Child-Pugh Class B or C) by medical record review.1","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.","Concurrent participation in another clinical trial of an investigational medicinal product.","Pregnant or lactating either by self-report or medical record review","Glaucoma","Gastroparesis","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.","Bipolar, psychotic, alcohol use disorder, non-alcohol substance-induced disorders, or imminent danger to self or others","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",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":13,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":91},"Philadelphia","Pennsylvania","19104","United States",[82,87],{"name":83,"role":84,"phone":85,"email":86},"Chung Tse, MD","CONTACT","2153498222","Chung.Tse@Pennmedicine.upenn.edu",{"name":88,"role":84,"phone":89,"email":90},"Maureen DeMarshall, RN","2153498546","demarshm@pennmedicine.upenn.edu",{"lat":92,"lon":93},39.95238,-75.16362,[95,96],{"name":83,"role":84,"phone":85,"email":86},{"name":97,"role":84,"phone":89,"email":90},"Maureen DeMarshall, BSN, RN",[],[100,104,107],{"pmid":101,"type":102,"citation":103},"37160297","RESULT","Birkinshaw H, Friedrich CM, Cole P, Eccleston C, Serfaty M, Stewart G, White S, Moore RA, Phillippo D, Pincus T. Antidepressants for pain management in adults with chronic pain: a network meta-analysis. Cochrane Database Syst Rev. 2023 May 10;5(5):CD014682. doi: 10.1002\u002F14651858.CD014682.pub2.",{"pmid":105,"type":102,"citation":106},"40258375","Khasawneh M, Mokhtare M, Moayyedi P, Black CJ, Ford AC. Efficacy of gut-brain neuromodulators in irritable bowel syndrome: an updated systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2025 Jun;10(6):537-549. doi: 10.1016\u002FS2468-1253(25)00051-2. Epub 2025 Apr 18.",{"pmid":108,"type":102,"citation":109},"26600836","Daghaghzadeh H, Naji F, Afshar H, Sharbafchi MR, Feizi A, Maroufi M, Tabatabaeeyan M, Adibi P, Tavakoli H. Efficacy of duloxetine add on in treatment of inflammatory bowel disease patients: A double-blind controlled study. J Res Med Sci. 2015 Jun;20(6):595-601. doi: 10.4103\u002F1735-1995.165969.",[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Inflammatory Bowel Disease",[],{"nct_id":4,"found":15,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an open-label, single-arm pilot study, meaning all participants will receive duloxetine, and both you and the study team will know what treatment you are getting. It plans to enroll 32 participants.","completed","Duloxetine for Inflammatory Bowel Diseases","This study is looking at how duloxetine, a medication used for depression and nerve pain, might help adults with Inflammatory Bowel Diseases (IBD). Researchers want to see if duloxetine can improve problems like anxiety, depression, and how IBD affects daily life. You might be able to join if you are over 24 years old and have significant psychological distress or moderate-to-severe IBD-related disability. The main goal is to see if duloxetine changes your IBD-related disability after 6 weeks. The current status of this study is unclear, and it plans to enroll 32 participants.","The primary endpoint measures changes in IBD-related disability at 6 weeks, after which there is a 2-week tapering period for the medication.",93,"You will take duloxetine daily for 6 weeks, starting with a lower dose and potentially increasing it. There will also be a 2-week tapering period at the end of treatment, and you will complete patient-reported outcome questionnaires at regular times.","Not stated in the trial record.",[31],"v2"]