🔎 Trials Near Me

Home › Inflammatory Bowel Disease › NCT07431606

Duloxetine in Inflammatory Bowel Diseases

RecruitingPhase 2

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

Sponsor: University of Pennsylvania · Participants: 32 · Started: May 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07431606

Locations in the U.S.

PennsylvaniaUniversity 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.