IBD (general)Recruiting
Duloxetine in Inflammatory Bowel Diseases
Phase 2 · Testing Duloxetine · 1 site · University of Pennsylvania
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Duloxetine (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases.
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 24 and older
- Any sex
Some of the main requirements, copied from the record:
- 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:
- elevated psychological distress (Distress Thermometer score > 4),10-12
Plus 2 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 32 participants are expected to take part.
- Start date: 2026-05-01.
- Main results expected around 2027-03-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Change in IBD-related disability (6 weeks)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | University of Pennsylvania |
| Enrollment | 32 (estimated) |
| Start date | 2026-05-01 |
| Primary completion (est.) | 2027-03-01 |
| First posted | 2026-02-24 |
| Last updated | 2026-07-16 |
| Official title | A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress |
| ClinicalTrials.gov ID | NCT07431606 |
Interventions
- Duloxetine (Drug)
antidepressant; central neuromodulator
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania | Philadelphia, Pennsylvania | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.