Duloxetine in Inflammatory Bowel Diseases
ConditionInflammatory Bowel Diseases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age24+
SponsorUniversity of Pennsylvania
About this trial
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
Eligibility criteria
Qualifiers
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.)
elevated psychological distress (Distress Thermometer score > 4),10-12
moderate-to-severe IBD-related disability (IBD-DI score ≥ 356, 7), or
elevated GI-specific anxiety (Visceral Sensitivity Index > 10) -
Disqualifiers
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
Trial design
Treatments tested in this trial
- Duloxetine
Treatment groups
32 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov