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Duloxetine for Inflammatory Bowel Diseases

This study is looking at how duloxetine, a medication used for depression and nerve pain, might help adults with Inflammatory Bowel Diseases (IBD). Researchers want to see if duloxetine can improve problems like anxiety, depression, and how IBD affects daily life. You might be able to join if you are over 24 years old and have significant psychological distress or moderate-to-severe IBD-related disability. The main goal is to see if duloxetine changes your IBD-related disability after 6 weeks. The current status of this study is unclear, and it plans to enroll 32 participants.

Study design
This is an open-label, single-arm pilot study, meaning all participants will receive duloxetine, and both you and the study team will know what treatment you are getting. It plans to enroll 32 participants.
What's involved
You will take duloxetine daily for 6 weeks, starting with a lower dose and potentially increasing it. There will also be a 2-week tapering period at the end of treatment, and you will complete patient-reported outcome questionnaires at regular times.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in IBD-related disability at 6 weeks, after which there is a 2-week tapering period for the medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07431606

Duloxetine in Inflammatory Bowel Diseases

Recruiting
PHASE2Ages 24+InterventionalTreatment
University of Pennsylvania
~32 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Duloxetine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in IBD-related disability
Measured over 6 weeks

Conditions

Inflammatory Bowel Diseases

Explore related trials

Inflammatory Bowel Disease

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Chung Tse, MD
[email protected]
2153498222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:

Exclusion

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

What this trial measures

  • Change in IBD-related disability6 weeks

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