NCT07431606

Duloxetine in Inflammatory Bowel Diseases

A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 24 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	Duloxetine	antidepressant; central neuromodulator

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-10-31
• First posted: 2026-02-24
• Last updated: 2026-02-24