A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress
University of Pennsylvania
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
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…
Eligibility
- Age range
- 24+ years
- Sex
- All
- Healthy volunteers
- No
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 reu…
Interventions
- DrugDuloxetine
antidepressant; central neuromodulator
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania