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Duloxetine in Inflammatory Bowel Diseases

NCT07431606 · University of Pennsylvania
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Official title
A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress
About this study
Subjects will be screened and enrolled once PI confirms eligibility. After patient signs consent: Duloxetine 30 mg orally daily will be administered for 1 week (age \<65 years) or 2 weeks (age ≥65 years), then increased to duloxetine 60 mg orally daily, if tolerated. Patients may continue duloxetine 30 mg if they do not tolerate duloxetine 60 mg. Patients 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. Patient reported outcomes will be completed at set intervals.
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
Study design
Enrollment target: 32 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-01
Estimated completion: 2027-10-31
Last updated: 2026-07-16
Interventions
Drug: Duloxetine
Primary outcomes
  • Change in IBD-related disability (6 weeks)
Sponsor
University of Pennsylvania · other
Contacts & investigators
ContactChung Tse, MD · contact · Chung.Tse@Pennmedicine.upenn.edu · 2153498222
ContactMaureen DeMarshall, BSN, RN · contact · demarshm@pennmedicine.upenn.edu · 2153498546
All locations (1)
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States