Duloxetine to help mood and function in adults with inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, open-label, single-arm pilot study evaluating duloxetine for improving psychological distress and functional limitations in adults with inflammatory bowel disease. Participants start duloxetine at 30 mg daily (adjusted by age) and may increase to 60 mg daily for 6 weeks, followed by a 2-week taper. Patient-reported outcomes on anxiety, depression, and IBD-related disability are collected at predefined intervals to assess feasibility, tolerability, and preliminary signals of efficacy. The study emphasizes gut-brain axis symptoms and aims to provide data to guide future research in this area.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Chung Tse, MD
• Email: Chung.Tse@Pennmedicine.upenn.edu
• Phone: 2153498222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.