Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Duloxetine

    Drug

    antidepressant; central neuromodulator

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: DuloxetineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in IBD-related disability

IBD Disability Index scores, range 0-100, higher score indicates more disability

Time frame
6 weeks

Secondary outcomes

1

Changes in psychological distress

Depression Anxiety and Stress Scale (DASS-21), range 0-21, higher scores indicate higher distress Distress Thermometer, range 0-10, higher scores indicate higher distress

Time frame
6 weeks
2

Tolerability and safety

Determine the tolerability and safety of duloxetine (30-60 mg daily)

Time frame
6 weeks
3

Changes in gastrointestinal-specific anxiety

Visceral Sensitivity Index (VSI), range 0-75, higher scores indicate more gastrointestinal-specific anxiety

Time frame
6 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: