Inflammatory Bowel Diseases
Conditions
Brief 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.
Interventions
DRUGDuloxetine
antidepressant; central neuromodulator
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Years to No maximum
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 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 * Severe renal impairment (on dialysis; chronic kidney disease stage 4-5; acute kidney injury with glomerular filtration rate \<30 mL/minute) by medical record review of labs performed within 18 months. * Concurrent participation in another clinical trial of an investigational medicinal product. * Pregnant or lactating either by self-report or medical record review * Glaucoma * Gastroparesis * Use of medications that could lead to serious interactions with the study medication: potent CYP1A2 inhibitors, antidepressants (including serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, buspirone, thioridazine), linezolid, intravenous methylene blue, triptans, lithium, fentanyl, tramadol, meperidine, methadone, tryptophan, amphetamines, and St. John's Wort. * Bipolar, psychotic, alcohol use disorder, non-alcohol substance-induced disorders, or imminent danger to self or others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in IBD-related disability | 6 weeks | IBD Disability Index scores, range 0-100, higher score indicates more disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in psychological distress | 6 weeks | 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 |
| Tolerability and safety | 6 weeks | Determine the tolerability and safety of duloxetine (30-60 mg daily) |
| Changes in gastrointestinal-specific anxiety | 6 weeks | Visceral Sensitivity Index (VSI), range 0-75, higher scores indicate more gastrointestinal-specific anxiety |
Countries
United States
Contacts
CONTACTChung Tse, MD
CONTACTMaureen DeMarshall, BSN, RN
Outcome results
None listed