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Duloxetine in Inflammatory Bowel Diseases
A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress
Who can join
Ages 24 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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: 1. elevated psychological distress (Distress Thermometer score \> 4),10-12 2. moderate-to-severe IBD-related disability (IBD-DI score ≥ 356, 7), or 3. elevated GI-specific anxiety (Visceral Sensitivity Index \> 10) - Exclusion Criteria: * 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 \<30 mL/minute) 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
About the study
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
What is being tested
- Duloxetine (drug)
Sponsor: University of Pennsylvania · Participants: 32 · Started: May 1, 2026
Contact the study team
- Chung Tse, MD · Phone: 2153498222
- Maureen DeMarshall, BSN, RN · Phone: 2153498546
Official record on ClinicalTrials.gov — NCT07431606
Locations in the U.S.
| Pennsylvania | University of Pennsylvania, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.