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Duloxetine for IBD-Related Disability and Distress
NCT07431606Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2026
- Primary completion
- Mar 2027
- Countries
- 1
- Sponsor
- University of Pennsylvania
- Modality
- Small Molecules
- Drugs
- duloxetine
- Conditions
- psychological distressanxiety disorder
01
Overview
Phase 2, open-label, single-arm trial of duloxetine in psychological distress and anxiety disorder, sponsored by University of Pennsylvania. Primary endpoint: Change in IBD-related disability at 6 weeks. Started May 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Duloxetine
Duloxetine 30-60 mg daily per oral
03
Who it enrols
Adults >24 years with IBD and elevated psychological distress, IBD-related disability, or GI-specific anxiety, excluding those on concomitant antidepressants or with severe hepatic/renal impairment.
04
Endpoints
Primary
Change in IBD-related disability
Secondary
Changes in psychological distress
Tolerability and safety
Changes in gastrointestinal-specific anxiety
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