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.
Eligibility Criteria
Age Range: 24 years to No maximum
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